Intco FDA
EU representative : MedNet EC-REP C IIb GmbH (Germany) and 1 other
China
67 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Technogym
Italy
58 others
I, IIa
MDR
prrc@technogym.com
EUDAMED record
Report an error
ASA FDA
Italy
40 others
I, IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Redcord
Norway
32 others Redcord Ceiling Suspension, 26-87cm Redcord Ceiling Suspension, Axis/Mini Redcord Ceiling Suspension, Mini Redcord Ceiling Suspension, Trainer standard Redcord Doorfix, one pair Redcord Elastic cord 30cm, black Redcord Elastic cord 30cm, red Redcord Elastic cord 60cm, black Redcord Elastic cord 60cm, red Redcord Home Gym Redcord Mat Redcord Mini Redcord Mini Extra Redcord Narrow sling Redcord Portable Gym Redcord PowerGrip, one pair Redcord Rehab Pro Redcord Rehab Pro Plus Redcord Roll Redcord Rope 30cm, one pair Redcord Rope 5m Redcord Rope 60cm, one pair Redcord Rope Set for upgrading Redcord Sliding Suspension System III Redcord Split sling Redcord Strap, one pair Redcord Tandem Station Redcord Trainer Redcord Wide sling Redcord Workstation Professional Redcord Workstation Professional, Floor stand Redcord Workstation Professional, Wall stand
I
MDR
Website
EUDAMED record
Report an error
Wrmed FDA
EU representative : MDSS GmbH (Germany)
United States
31 others 0130 0134 0136 0138 0146 0150 0151 0152 0153 0154 0159 0161 0162 0163 0169 0174 0175 Therabath, TB10 ADJ, PeachE, 220V 93/42 Therabath, TB10 ADJ, ScentFree, 220V 93/42 Therabath, TB7, Cranberry Zest, 220V 93/42 Therabath, TB7, Blooming Lilacs, 220V 93/42 Therabath, TB7, Cucumber Thyme, 220V 93/42 Therabath, TB7, Eucalyptus Rosemary Mint 220V 93/42 Therabath, TB7, Fresh Squeezed Lemon, 220V 93/42 Therabath, TB7, Lavender Harmony, 220V 93/42 Therabath, TB7, PeachE, 220V 93/42 Therabath, TB7, ScentFree, 220V 93/42 Therabath, TB7, Vanilla Cupcake, 220V 93/42 Therabath, TB7, w/o Wax, 220V 93/42 Therabath, TB7, Warm Apple Spice, 220V 93/42 Therabath, TB7, Wintergreen, 220V 93/42
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Meden
Poland
30 others BALMED ECO BALMED ECO AIR BATHAID ECONOMY CHIROSPACE E2.C4-H SAFARI BUFFALO, SAFARI ELEPHANT EKOPOMPA I ELEPHANT B-S1.F4 B-S1.F0, B-S1.F4, B-S2.F0, B-S2.F4, B-S1.F4-H, B-S2.F0-H, B-S2.F4-H, B-S2.F4-H ELEVEO FIRE S3.F0 TERAPEUTA, MONTANE, PRESTIGE, Z-ULTIMATE, ELEMENTAL GALAXY TRACTION T3.F0 T3.F0 XL Hoptop InVacMed LEOPARD S3.F0 Z-ADVANCED, NEXUS, SAFARI, FLOW, MATERA, GALAXY LZM 3 LZM 1, 2, 3, Colombia MARS / WENUS MEDCART, WINBACK, QUBIC MERCURY S4.F0-H NEXUS, SAFARI, GALAXY, Z-ADVANCED NBC1 ORKAN NPL2 BRYZA PACIFIC FIJI E5, P5, P7; PACIFIC HAWAII S2,S4,E2 PIO SAFARI ELEPHANT B-S1.F0-H SAFARI ELEPHANT B140-S1.2F2 SOLMED DUO SOLMED UNO, DUO, TRIO TERAPEUTA E-S2.F0, E-S2.F4 TRITON 6E TRITON 6M, 6E UCS VERTIMO CLASSIC, HI-LO UNO, HI-LO DUO, HI-LO DUO+ WaveMOTION ELLIPSE S1,S2,S4 WKD, WKS, WKD, WKR
I, IIa
MDR
Website
eudamed@meden.com.pl
EUDAMED record
Report an error
Medexim
Slovakia
29 others
IIa
93/42
Website
EUDAMED record
Report an error
Thor Sagli̇k Spor Malzemeleri̇ Ve Rehabi̇li̇taston Si̇stemleri̇ Medi̇kal Yazilim Sanayi̇ Ti̇caret Si̇rketi̇
Türkiye
25 others
I
MDR
Website
info@thormedikal.com
EUDAMED record
Report an error
Yishunmedical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Cold & Hot Face Mask YS-MZ200, YS-MZ220,YS-MZ230,YS-MZ240,YS-MZ250 Fabric Bag YS-BBD05,YS-BBD06,YS-BBD07,YS-BBD09,YS-BBD11 2 refs Frozen Ice Pack YS-BDA50,YS-BDA100,YS-BDA150,YS-BDA200,YS-BDA250,YS-BDA500,YS-BDB50,YS-BDB100,YS-BDB150,YS-BDB200,YS-BDB250,YS-BDB500,YS-BDC50,YS-BDC100,YS-BDC150,YS-BDC200,YS-BDC250,YS-BDC500,etc. 2 refs Gel Sleeve YS-LRD50,YS-LRD60,YS-LRD100,YS-LRD120,YS-LRD130,YS-LRD140,YS-LRD150,YS-LRD200,YS-LRD220,YS-LRD250,YS-LRD270,YS-LRD280,YS-LRD320,YS-LRD350,YS-LRD430,YS-LRD475,YS-LRD500, YS-LRD600,etc 2 refs Hot Cold Eye Mask YS-YZ30,YS-YZ58,YS-YZ60,YS-YZ65,YS-YZ80,YS-YZ99,YS-YZ100,YS-YZ101,YS-YZ110,YS-YZ120,YS-YZ125,YS-YZ130,YS-YZ140,YS-YZ150,YS-YZ160,YS-YZ180,YS-YZ80,YS-YZ160,YS-YZ200,YS-YZ240,YS-YZ260,YS-BQ125,YS-YT4,YS-YT6,YS-YT10,YS-YT15,YS-YT20
24 others Hot Cold Pack YS-LRA50,YS-LRA60,YS-LRA100,YS-LRA120,YS-LRA130,YS-LRA140,YS-LRA150,YS-LRA170,YS-LRA200,YS-LRA220,YS-LRA250,YS-LRA270,YS-LRA280,YS-LRA320,YS-LRA350,YS-LRA475,YS-LRA500,YS-LRA520,YS-LRA540,YS-LRA550,YS-LRA560,YS-LRA580,YS-LRA600,YS-LRA650,YS-etc 3 refs Hot Cold Pack YS-LRB50,YS-LRB60,YS-LRB100,YS-LRB120,YS-LRB130,YS-LRB140,YS-LRB150,YS-LRB180,YS-LRB200,YS-LRC40,YS-LRC50,YS-LRC55,YS-LRC60,YS-LRC70,YS-LRC85,YS-LRC100,YS-LRC120,YS-LRC130,YS-LRC140,YS-LRC150,YS-LRC200,etc 3 refs Hot Compress Pack YS-RFA165,YS-RFA245,YS-RFA265,YS-RFA380,YS-RFA420,YS-RFB150,YS-RFB370,YS-RFB450,YS-RFB500,YS-RFB570,YS-RFB800,YS-RFB950,YS-RFB1130,etc. 2 refs Hot Pack YS-NSD100 93/42 Hot Pack YS-NSD110 93/42 Hot Pack YS-NSD25 93/42 Hot Pack YS-NSD25,YS-NSD35,YS-NSD40,YS-NSD60,YS-NSD63,YS-NSD65,YS-NSD70,YS-NSD75,YS-NSD80,YS-NSD90,YS-NSD100,YS-NSD110,YS-NSD600,YS-NSD1000 2 refs Hot Pack YS-NSD35 93/42 Hot Pack YS-NSD40 93/42 Hot Pack YS-NSD60 93/42 Hot Pack YS-NSD65 93/42 Hot Pack YS-NSD70 93/42 Hot Pack YS-NSD75 93/42 Hot Water Bag YS-RFA165,YS-RFA245,YS-RFA265,YS-RFA380,YS-RFA420 2 refs Instant Cold Pack YS-SL100 93/42 Instant Cold Pack YS-SL100,YS-SL110,YS-SL133,YS-SL160,YS-SL180,YS-SL200,YS-SL220,YS-SL225,YS-SL280,YS-SL290 3 refs Instant Cold Pack YS-SL133 93/42 Instant Cold Pack YS-SL160 93/42 Instant Cold Pack YS-SL250 93/42 Instant Cold Pack YS-SL280 93/42 Instant Cold Pack YS-SL290 93/42 Instant Hot Pack YS-SR100 93/42 Instant Hot Pack YS-SR100,YS-SR250 2 refs Instant Hot Pack YS-SR250 93/42
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Megoafek FDA
EU representative : MedNet EC-REP GmbH (Germany)
Israel
23 others
I, IIa
MDR
Website
info@megoafek.com
EUDAMED record
Report an error
Technomex FDA
Poland
23 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
BTL Industries FDA
EU representative : BTL ITALIA S.r.l. (Italy)
United Kingdom (ex Northern Ireland)
22 others
I, IIa, IIb
MDR
EUDAMED record
Report an error
Kinesis
Poland
23 others
I
MDR
Website
EUDAMED record
Report an error
FREI medical
Germany
20 others
I
MDR
Website
info@frei-ag.de
EUDAMED record
Report an error
Enraf-Nonius FDA
Netherlands
20 others
I, IIa, IIb
MDR, 93/42
Website
info@enraf-nonius.nl
EUDAMED record
Report an error
Fisioline FDA
Italy
19 others
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Biomag
Czechia
17 others
IIa
MDR
Website
EUDAMED record
Report an error
Silverfox FDA
EU representative : Lotus NL B.V. (Netherlands)
China
16 others
I
MDR
Website
sales@silverfox.cn
EUDAMED record
Report an error
Capenergy FDA
Spain
14 others
IIa, IIb
MDR, 93/42
Website
info@capenergy.com
EUDAMED record
Report an error
Fisiopress
Italy
14 others
IIa
MDR, 93/42
info@fisiopress.com
EUDAMED record
Report an error
Gyrus ACMI FDA
EU representative : Olympus Europa SE & Co. KG (Germany)
United States
14 others
I, IIa, IIb
MDR, 93/42
EUDAMED record
Report an error
CICO
Italy
13 others
IIa
93/42
EUDAMED record
Report an error
Davidhealth FDA
Finland
13 others
I
93/42
info@davidhealth.com
EUDAMED record
Report an error
gbo Medizintechnik FDA
Germany
13 others
IIa
MDR, 93/42
info@gbo-ag.de
EUDAMED record
Report an error
Mectronic Medicale FDA
Italy
13 others
IIb
MDR, 93/42
info@mecmedix.com
EUDAMED record
Report an error
Rfxcare FDA
EU representative : RFX+Care International A/S (Denmark)
China
13 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Solta FDA
EU representative : MDSS GmbH (Germany)
United States
12 others
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Astar
Poland
11 others
IIa, IIb
MDR
Website
eudamed@astar.eu
EUDAMED record
Report an error
Unbescheiden
Germany
11 others
I, IIa
MDR, 93/42
Website
info@unbescheiden.com
EUDAMED record
Report an error
Xiamen Senyang FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
11 others
IIa
93/42
EUDAMED record
Report an error
Beurer
Germany
10 others
IIa
MDR, 93/42
info@beurer.de
EUDAMED record
Report an error
Reha Fund
Poland
9 others
I
MDR
Website
EUDAMED record
Report an error
Termosalud FDA
Spain
9 others
IIa, IIb
MDR, 93/42
regulatory@termosalud.com
EUDAMED record
Report an error
Antar
Poland
8 others
I
MDR
Website
EUDAMED record
Report an error
Dermadry FDA
EU representative : CEpartner4U (Netherlands)
Canada
8 others
I, IIa
MDR, 93/42
Website
support@dermadry.com
EUDAMED record
Report an error
JMS- Indústria de Mobiliário Hospitalar
Portugal
8 others
I
MDR
Website
EUDAMED record
Report an error
PRIM FDA
Spain
8 others
I, IIa
MDR
Website
eudamed1@prim.es
EUDAMED record
Report an error
Zimmer FDA
Germany
8 others
I, IIa
MDR, 93/42
Website
info@zimmer.de
EUDAMED record
Report an error
Og Wellness Technologies Headquarters
EU representative : Emergo Europe B.V. (Netherlands)
Japan
16 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
BEMER Int FDA
Liechtenstein
7 others
IIa
MDR, 93/42
Website
regulatory@bemergroup.com
EUDAMED record
Report an error
Cardinalhealth FDA
EU representative : Cardinal Health Ireland Manufacturing Limited (Ireland)
United States
7 others
I, IIa
MDR
Website
EUDAMED record
Report an error
Diers FDA
Germany
7 others
I
MDR
Website
EUDAMED record
Report an error
Sensor Medica FDA
Italy
7 others
I
MDR
Website
info@sensormedica.com
EUDAMED record
Report an error
Zenith Technical Innovations FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
7 others
I, IIa
MDR
EUDAMED record
Report an error
PINO Pharmazeutische Präparate
Germany
7 others
I
MDR
Website
service@pinoshop.com
EUDAMED record
Report an error
Dbc
Finland
6 others
I
MDR
Website
EUDAMED record
Report an error
Actegy FDA
EU representative : MDSS GmbH (Germany)
United Kingdom (ex Northern Ireland)
5 others
IIa
93/42
Website
info.uk@actegy.com
EUDAMED record
Report an error
ekamed
Germany
5 others
I
MDR
Website
info@ekamed.de
EUDAMED record
Report an error
Elektronika I Elektromedycyna Mlewandowski J
Poland
5 others
IIa
MDR
Website
office@eie.com.pl
EUDAMED record
Report an error
Juventas
Poland
5 others
I
MDR
EUDAMED record
Report an error
Kernelmed FDA
EU representative : Caretechion GmbH (Germany)
China
5 others
IIa
93/42
EUDAMED record
Report an error
MediRobotic technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
5 others
IIa
MDR
EUDAMED record
Report an error
Meilan FDA
EU representative : Lotus NL B.V. (Netherlands)
China
5 others
IIa
MDR
EUDAMED record
Report an error
Yingchitech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
5 others
IIa
93/42
Website
EUDAMED record
Report an error
BÖSL Medizintechnik
Germany
4 others
I, IIa
MDR
Website
info@boesl-med.de
EUDAMED record
Report an error
Hakomed
Italy
4 others
IIb
93/42
Website
EUDAMED record
Report an error
InSightec FDA
EU representative : Obelis s.a. (Belgium)
Israel
4 others
I, IIb
MDR
Website
EUDAMED record
Report an error
Kinvent FDA
France
4 others
I
MDR, 93/42
Website
info@k-invent.com
EUDAMED record
Report an error
Longest FDA
EU representative : Lotus NL B.V. (Netherlands) and 1 other
China
4 others
IIa
MDR, 93/42
Website
service@longest.cn
EUDAMED record
Report an error
Tianjin Fuqin Science & Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
4 others
IIa
MDR
EUDAMED record
Report an error
Xiamen Weiyou Intelligent Technology FDA
EU representative : Sungo Cert GmbH (Germany)
China
4 others
IIa
MDR
EUDAMED record
Report an error
4Fizjo
Poland
3 others
I
MDR
Website
EUDAMED record
Report an error
Biocompression FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
3 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Domino FDA
Italy
3 others
I
MDR
Website
quality@globusitalia.com
EUDAMED record
Report an error
Fast Therapies
Italy
3 others
IIa
MDR
Website
info@fasttherapies.com
EUDAMED record
Report an error
Innow
Poland
3 others
I
MDR
marketing2@innow.pl
EUDAMED record
Report an error
Medency FDA
Italy
3 others
I
MDR
Website
info@medency.com
EUDAMED record
Report an error
Medicapteurs
France
3 others
I
MDR
Website
info@medicapteurs.fr
EUDAMED record
Report an error
Novafon
Germany
3 others
I, IIa
MDR
Website
info@novafon.de
EUDAMED record
Report an error
TensCare FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
3 others
IIa
MDR
Website
QA@tenscare.co.uk
EUDAMED record
Report an error
Alegio
Italy
2 others
I
MDR
EUDAMED record
Report an error
Chongqing Xinfeng Medical Instruments FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
2 others
IIa
93/42
Website
EUDAMED record
Report an error
Deka
Italy
2 others
IIa, IIb
MDR, 93/42
Website
info@deka.it
EUDAMED record
Report an error
Eureduc
France
2 others
I, IIa
93/42
Website
info@eureduc.eu
EUDAMED record
Report an error
Guangzhou Yikang Medical Equipment Industrial FDA
EU representative : Share info GmbH (Germany)
China
2 others
IIa
MDR
EUDAMED record
Report an error
Netop FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
Allergy Reliever MC-001 93/42 Allergy Reliever MC-001, MC-004, MC-008, MC-008A, MC-010C 3 refs Allergy Reliever MC-008 93/42 Cure Trio MC-310 93/42 Cure Trio MC-310(Android),MC-310(iOS), MC-310A, MC-310O, MC-310P, MC-310Q, MC-310R, MC-310S, MC-310T, MC-310U, MC-310Y, MC-310B, MC-310C, MC-310D, MC-310E, MC-310F, MC-310G, MC-310H, MC-310I, MC-310M 3 refs
2 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Sedatelec FDA
France
2 others
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Shenzhen Dongdixin Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
2 others
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Tensplus FDA
EU representative : Caretechion GmbH (Germany)
Hong Kong SAR China
2 others
I, IIa
MDR
EUDAMED record
Report an error
VERTIGO di CARLO TACCHINO
Italy
2 others
I
MDR
EUDAMED record
Report an error
Wonjin Mulsan FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
2 others
IIa
MDR
Website
EUDAMED record
Report an error
Sublimed FDA
France
3 others
I, IIa
MDR, 93/42
Website
PRRC-Sublimed@subli-med.com
EUDAMED record
Report an error
Artzt
Germany
1 other
I
MDR
Website
info@artzt.eu
EUDAMED record
Report an error
Brownmed FDA
EU representative : AR Experts B.V. (Netherlands)
United States
1 other
I
MDR
EUDAMED record
Report an error
Guangzhou Xinbo Electronic FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
1 other
IIa
93/42
EUDAMED record
Report an error
Habys
Poland
1 other
I
MDR
info@habys.pl
EUDAMED record
Report an error
Halcamp
Poland
1 other
I
MDR
EUDAMED record
Report an error
Jiangsu Hanyao Medical Devices FDA
EU representative : HUMISS TRADING S. L. (Spain)
China
1 other
IIa
MDR
EUDAMED record
Report an error
Koolcare FDA
EU representative : Prolinx GmbH (Germany)
China
BIPA BI LFE Wärmegürtel KK-IW-N 45 3 refs Dr. Max Cooling Patches 2 refs Dr. Max Hot&Cold Therapy 3 refs Dr. Max Instant Cold Pack 2 refs KK-IW-N(40B,45B,70B,50B,49B,48B,55B,44B,42B,37B,30B,36B,25B,39B,34B,62B,60B,65B,72B,82B,75B,80B,120B),KK-IW-N(40D,45D,70D,50D,49D,48D,55D,44D,42D,37D,30D,36D,25D,39D,34D,62D,60D,65D,72D,82D,75D,80D,120D,215D, 185D,175D)
1 other Nexcare™ Heat Patch KK-IW-N(40A,45A,70A,50A,49A,48A,55A,44A,42A,30A,36A,25A,39A,34A,62A,60A,65A,72A,82A,75A,80A,120A),KK-IW-N(40C,45C,70C,50C,49C,48C,55C,44C,42C,30C,36C,25C,35C,39C,34C,62C,60C,65C,72C,82C,75C,80C,120C,215C,185C,175C) 3 refs
I, IIa
MDR
Website
EUDAMED record
Report an error
Livetec
Germany
1 other
IIb
MDR, 93/42
Website
info@livetec.de
EUDAMED record
Report an error
MediTouch
EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)
Israel
1 other
I
MDR
Website
info@meditouch.co.il
EUDAMED record
Report an error
Sunnyou
EU representative : Lotus NL B.V. (Netherlands)
China
1 other
I, IIa
MDR
EUDAMED record
Report an error
TECH-MED Roman Pasławski Spółka Jawna
Poland
1 other
I
MDR
Website
EUDAMED record
Report an error
Theraclion
France
1 other
I, IIb
MDR, 93/42
Website
contact@theraclion.com
EUDAMED record
Report an error
Tma Medical Equipment
EU representative : TSI Quality Services (Denmark)
United Kingdom (ex Northern Ireland)
1 other
I
MDR
EUDAMED record
Report an error
Zero-Plus International
EU representative : Globalmind consumer electronics GmbH (Germany)
Hong Kong SAR China
1 other
IIa
93/42
EUDAMED record
Report an error
Jeisys FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
1 other
IIb
93/42
Website
EUDAMED record
Report an error
Acus Med
Poland
I
MDR
Website
info@acusmed.pl
EUDAMED record
Report an error
Biomedical FDA
Italy
IIa, IIb
93/42
Website
info@biomedical-bio.net
EUDAMED record
Report an error
Bioswing
Germany
I
MDR
Website
info@bioswing.de
EUDAMED record
Report an error
Changsha Fourier Medical Technology
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
China
I, IIa
MDR
Website
info@fftai.com
EUDAMED record
Report an error
Emblation FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
IIb
93/42
Website
info@emblation.com
EUDAMED record
Report an error
Kinetec FDA
France
IIa
MDR
contact@kinetec.fr
EUDAMED record
Report an error
Laboratoires I2M
France
IIa
93/42
Website
EUDAMED record
Report an error
Med Elettronica
Italy
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Orgaterm
Germany
I
93/42
Website
info@orgaterm.de
EUDAMED record
Report an error
Project Blue Generation
Italy
IIa, IIb
93/42
EUDAMED record
Report an error
SCHNELL Trainingsgeräte
Germany
I
MDR
Website
info@schnell-training.com
EUDAMED record
Report an error
Schupp
Germany
I
MDR
Website
EUDAMED record
Report an error
Shanghai Chuangshi Medical Technology (Group) FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
Yelatma Instrument-Making Enterprise Joint-Stock
EU representative : QbD RepS BV (Belgium)
Russia
IIa
93/42
Website
EUDAMED record
Report an error
Arjo FDA
Sweden
I, IIa
MDR
Website
info@arjo.com
EUDAMED record
Report an error
Berger&Kraft Medical
Poland
IIb
93/42
Website
regulatory@bergerandkraft.com
EUDAMED record
Report an error
BTS FDA
Italy
I
MDR
info@btsbioengineering.com
EUDAMED record
Report an error
Canyon Medical FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
Website
EUDAMED record
Report an error
Ceragem FDA
EU representative : Ceragem Europe GmbH (Germany)
South Korea
IIa
MDR, 93/42
EUDAMED record
Report an error
Chongqing Haifu Technology
EU representative : MDSS GmbH (Germany)
China
I, IIb
MDR, 93/42
EUDAMED record
Report an error
Daesung Maref FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Daeyangmed FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa, IIb
MDR, 93/42
sales1@daeyangmed.com
EUDAMED record
Report an error
Easytech
Italy
I, IIa, IIb
MDR
info@easytechitalia.com
EUDAMED record
Report an error
EMS Physio FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Hans Dinslage
Germany
IIa
MDR
service@sanitas-online.de
EUDAMED record
Report an error
Henan Kangdi Medical Devices
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
China
Heat Pads 10x20cm 93/42 Heat Pads 10x20cm,10x13cm,7.4x11.2cm,7x9cm,9.6x12.8cm,5.5x9.2cm Heat Pads 7x9cm 93/42 Pain relief patch 12cmx18cm, 10cmx18cm, 11cmx15cm, 10cmx15cm, 10cmx13cm, 10cmx11cm, 8.4cmx12.5cm, 7cmx10cm, 6.5cmx4.2cm, 6.5cmx15cm
I, IIa
MDR, 93/42
EUDAMED record
Report an error
IDS FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
ITO FDA
EU representative : MDSS GmbH (Germany)
Japan
IIa
93/42
EUDAMED record
Report an error
LED FDA
Italy
IIa, IIb
MDR
Website
info@led.it
EUDAMED record
Report an error
Ml Elettromedicali
Italy
IIa
93/42
Website
EUDAMED record
Report an error
Multiradiance FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
EUDAMED record
Report an error
Nantong Haochuan Industry FDA
EU representative : HUMISS TRADING S. L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Oezpinar
Germany
I
MDR
Website
EUDAMED record
Report an error
Physiomed FDA
Germany
I, IIa
MDR
Website
info@physiomed.de
EUDAMED record
Report an error
Physion
Italy
IIa
MDR, 93/42
info@physion.it
EUDAMED record
Report an error
RFH - Rehatechnik
Germany
I
MDR
Website
EUDAMED record
Report an error
Shanghai Wonderful Opto-Electrics Tech FDA
EU representative : Medwheat Tech Service GmbH (Germany)
China
IIb
93/42
Website
regulatory@wonderful-sh.com
EUDAMED record
Report an error
Thought Technology FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
I
MDR, 93/42
Website
EUDAMED record
Report an error
Trautwein
Germany
I
MDR
Website
info@trautwein-gmbh.com
EUDAMED record
Report an error
Unitekno
Italy
IIa
93/42
Website
info@unitekno.com
EUDAMED record
Report an error
Weihai Weibo Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIa
MDR
Website
EUDAMED record
Report an error
ZMI Electronics FDA
EU representative : mdi Europa GmbH (Germany)
Taiwan
I
MDR
Website
mail@zmi-electronics.com
EUDAMED record
Report an error
Acare Technology FDA
EU representative : Surpass Biomedical Europe B.V. (Netherlands)
Taiwan
I, IIa
MDR, 93/42
info@acarecorp.com
EUDAMED record
Report an error
Andon Health FDA
EU representative : iHealthLabs Europe SAS (France)
China
IIa
MDR, 93/42
EUDAMED record
Report an error
Armocon
EU representative : LELOi AB (Sweden)
China
I
MDR, 93/42
EUDAMED record
Report an error
axion FDA
Germany
IIa
MDR, 93/42
Website
service@axion-net.de
EUDAMED record
Report an error
Bohemia - Moor Sro
Czechia
I
MDR
EUDAMED record
Report an error
CeramOptec FDA
Germany
IIa, IIb
MDR
Website
EUDAMED record
Report an error
COMPEX, spol. s r.o FDA
Czechia
IIb
MDR
Website
info@jett.eu
EUDAMED record
Report an error
Cyberdyne FDA
EU representative : Cyberdyne Care Robotics GmbH (Germany)
Japan
IIa
MDR
regulatory_affairs@cyberdyne.jp
EUDAMED record
Report an error
Dia-Med Egészségügyi És Gépészeti Berendezéseket Gyártó És Forgalmazó Kft
Hungary
I
MDR
Website
EUDAMED record
Report an error
Easymed FDA
EU representative : mdi Europa GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Embitron
Czechia
IIa
93/42
Website
EUDAMED record
Report an error
Equa
Estonia
I
MDR
Website
info@equa.ee
EUDAMED record
Report an error
Fesia technology
Spain
IIa
MDR
Website
EUDAMED record
Report an error
FineMEC FDA
EU representative : MDSS GmbH (Germany)
South Korea
IIb
93/42
Website
EUDAMED record
Report an error
Fleming Medical
EU representative : Fleming Medical (Ireland)
China, Ireland
I, IIa
MDR, 93/42
Website
quality@flemingmedical.ie
EUDAMED record
Report an error
Foshan Hongfeng FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
I, IIa
MDR
Website
EUDAMED record
Report an error
Guangzhou Renlai Rehabilitation Equipment Manufacturing
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Hangzhou Zhengda Medical FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Heuser Apparatebau
Germany
I, IIa
MDR
Website
info@heuser-haan.de
EUDAMED record
Report an error
HLS Hypertech Laser Systems
Germany
IIa
93/42
Website
info@hypertech-lasers.de
EUDAMED record
Report an error
I-Tech Industries FDA
Italy
IIa
MDR
Website
info@i-techindustries.com
EUDAMED record
Report an error
Irradia
Sweden
IIa
MDR
Website
info@irradia.se
EUDAMED record
Report an error
Itaka way med
Italy
I
MDR
Website
EUDAMED record
Report an error
Konfort Ozel Saglik Hizmetleri Tibbi Malz San Ve Tic Sti
Türkiye
IIa
93/42
Website
info@confortostomi.com
EUDAMED record
Report an error
Laser Light Orvostechnikai Innovációs Kft
Hungary
IIa
93/42
Website
EUDAMED record
Report an error
Mandelay Magyarország Kft
Hungary
IIa
93/42
Website
info@vibeyoup.com
EUDAMED record
Report an error
Med & Life
Poland
IIa
93/42
Website
EUDAMED record
Report an error
Medcaptain FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR, 93/42
Website
info@medcaptain.com
EUDAMED record
Report an error
Medilogic FDA
Germany
I
MDR
Website
EUDAMED record
Report an error
Ml Fusion
France
I
MDR
Website
EUDAMED record
Report an error
Monath-Electronic
France
I
MDR
servicequalite@monath-electronic.fr
EUDAMED record
Report an error
NonDolens
Germany
IIa
93/42
Website
mail@nondolens.com
EUDAMED record
Report an error
NuStep
EU representative : Emergo Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
Report an error
Orthosxxi
Portugal
I
MDR
Website
info@orthosxxi.com
EUDAMED record
Report an error
Reimers & Janssen
Germany
IIa
MDR
Website
service@rj-laser.com
EUDAMED record
Report an error
Sensingfuture
Portugal
I
MDR
info@sensingfuture.pt
EUDAMED record
Report an error
Shenb FDA
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen PRO HITU Medical
EU representative : SUNGO Europe B.V. (Netherlands)
China
IIb
93/42
Website
marketing@pro-hifu.com
EUDAMED record
Report an error
Shenzhen Pump Medical System FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I, IIa
MDR, 93/42
marketing@bpump.com.cn
EUDAMED record
Report an error
Shenzhen Roundwhale Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
Combo Electrotherapy Device R-C1(MEX1/RW1/SA3), R-C3, R-C101A~L/W, R-C4A(AUS1/RW1~RW3/U12), R-C4B(AUS12/DE4/RW1), R-C4C(AUS1), R-C4D(RW1/U7/U9/WH1), R-E1, R-T1, F100, M100A(WH1), M101A(UK1/WH2), M102A, M103A, M104A, MINI-TENS-COMB, TENS3500 3 refs Combo Electrotherapy Device R-W100/R-W101/R-W200/R-W201 ( A~E each); R-I100/R-I200/R-I300/R-I400/R-I500/R-I600 (A~E each); R-H100A~E; R-C102/R-C103/R-C104/R-C105/R-C106/R-C108/R-C109/R-C110/R-C111/R-C112 (A~E each); R-C101S 3 refs Magnetic therapy device R-M100 3 refs
IIa
MDR
Website
EUDAMED record
Report an error
Shenzhen Vivolight Medical Device & Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR, 93/42
EUDAMED record
Report an error
Suzhou Medical Appliance Factory FDA
EU representative : Metrax GmbH (Germany)
China
I, IIa
MDR, 93/42
EUDAMED record
Report an error
Suzhou Minhua Medical Equipment FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Disposable Deep Vein Thrombosis Cuff V608-SC01, V608-SC02, V608-SC03, V608-SC04, V608-ST01, V608-ST02, V608-ST03, V608-ST04, V608-SF01, V608-SF02 V608-SC01R, V608-SC02R, V608-SC03R, V608-SC04R, V608-ST01R, V608-ST02R, V608-ST03R, V608-ST04R, V608-SF01R, V608-SF02R
I
MDR
EUDAMED record
Report an error
Terma
Poland
I
MDR
Website
EUDAMED record
Report an error
Treatlite
Sweden
IIa
93/42
Website
info@treatlite.se
EUDAMED record
Report an error
Vitberg
Poland
I, IIa
MDR, 93/42
Website
EUDAMED record
Report an error
WHTcare
EU representative : WINTECARE ESPAÑA, S.L. (Spain)
Switzerland
IIa, IIb
MDR, 93/42
info@whtcare.ch
EUDAMED record
Report an error
Zhuolu Jontelaser Manufacturing Technology FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
2El
Czechia
IIa
93/42
EUDAMED record
Report an error
Aacurat
Germany
I
MDR
Website
info@aacurat.de
EUDAMED record
Report an error
Adss FDA
EU representative : Prolinx GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Aid United(Jiangsu)Sports Goods
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
I
MDR
EUDAMED record
Report an error
Airex
EU representative : 3A Composites GmbH (Germany)
Switzerland
I
MDR
Website
info@my-airex.com
EUDAMED record
Report an error
AMI FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
93/42
EUDAMED record
Report an error
Aretechllc FDA
EU representative : MedEnvoy Global BV (Netherlands)
United States
I
MDR
Website
info@aretechllc.com
EUDAMED record
Report an error
Armedical
Poland
I
MDR
Website
EUDAMED record
Report an error
Bamateknoloji
Türkiye
IIa
MDR
Website
EUDAMED record
Report an error
be-on-market
Germany
I
MDR
info@be-on-market.com
EUDAMED record
Report an error
Beacmed
Italy
IIa
MDR
Website
info@beacmed.eu
EUDAMED record
Report an error
BEE Medic FDA
Germany
I
MDR
Website
prrc@beemedic.de
EUDAMED record
Report an error
Beijing KES Biology Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
Benergygroup
Italy
I
MDR
Website
EUDAMED record
Report an error
Bertec FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
info@bertec.com
EUDAMED record
Report an error
Beyazgrup
Türkiye
I
MDR
Website
EUDAMED record
Report an error
Bo&Bo FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
EUDAMED record
Report an error
Boen Healthcare FDA
EU representative : Everbiz GmbH (Austria)
China
I
MDR
Website
EUDAMED record
Report an error
BojongMC FDA
EU representative : Obelis s.a. (Belgium)
South Korea
Physiotherapy Apparatus SE-1000 93/42 Physiotherapy Apparatus SP-1100, SP-2100, SP-3100,SP-RB1000, SP-1100E, SP-2100E, SP-3100E, SP-1100WR, SP-1100S, SP-2100S, SP-3100S, SP-1100PS, SP-2100PS, SP-1100P, SP-1100PE, SP-2100P, SP-2100PE 93/42
I, IIa
93/42
Website
inform@bojongmc.co.kr
EUDAMED record
Report an error
Bredent FDA
Germany
IIb
MDR
Website
info-medical@bredent.com
EUDAMED record
Report an error
BTE Technologies FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
regulatory@btetechnologies.com
EUDAMED record
Report an error
Chirana Progress, s.r.o
Slovakia
I, IIa
MDR
Website
EUDAMED record
Report an error
Cinarmedikal
Türkiye
I
MDR
Website
info@cinarmedikal.com
EUDAMED record
Report an error
Classys FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
IIa
93/42
EUDAMED record
Report an error
Cometa FDA
Italy
I
MDR
Website
sales@cometasystems.com
EUDAMED record
Report an error
Cosmo Robotics FDA
EU representative : ExoAtlet Global S.A. (Luxembourg)
South Korea
IIa
MDR
Website
EUDAMED record
Report an error
Cura Farma
Italy
I
MDR
Website
EUDAMED record
Report an error
Curexo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIa
MDR, 93/42
EUDAMED record
Report an error
Draeger FDA
EU representative : Drägerwerk AG & Co. KGaA (Germany)
United States
I
MDR
Website
EUDAMED record
Report an error
Electrodynamics Manufacturing
Greece
IIa
93/42
EUDAMED record
Report an error
eXroid Technology
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
Website
raqamanager@exroid.com
EUDAMED record
Report an error
Fabrication Enterprises
EU representative : AJW Technology Consulting GmbH (Germany)
United States
I
MDR
Website
EUDAMED record
Report an error
Fisiostore
Italy
I
MDR
info@fisiostore.it
EUDAMED record
Report an error
Frida FDA
EU representative : Nasalprodukter Sverige AB (Sweden)
United States
I
MDR
Website
EUDAMED record
Report an error
Fusmobile FDA
EU representative : Donawa Lifescience Consulting Srl (Italy)
Israel
I, IIb
MDR
rani1@fusmobile.com
EUDAMED record
Report an error
Golden Star FDA
Italy
IIb
MDR
Website
EUDAMED record
Report an error
Goodmedica
Poland
IIa
MDR
Website
office@goodmedica.pl
EUDAMED record
Report an error
Guangzhou Fourier Intelligence
EU representative : MedNet EC-REP GmbH (Germany)
China
IIa
MDR
info@fftai.com
EUDAMED record
Report an error
Gymna
Belgium
IIa
MDR
Website
info@gymna-uniphy.com
EUDAMED record
Report an error
HeVaTech
Germany
I, IIa
MDR
Website
EUDAMED record
Report an error
HSD
EU representative : Quaser S.r.l. (Italy)
San Marino
IIa
MDR
info@hsd.sm
EUDAMED record
Report an error
Hygeamed FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIb
MDR
Website
service@hygeamed.com
EUDAMED record
Report an error
I.A.C.E.R
Italy
IIa
MDR
Website
EUDAMED record
Report an error
Icaros
Germany
I
MDR
Website
info@icaros.com
EUDAMED record
Report an error
Idrogenet FDA
Italy
IIa
93/42
EUDAMED record
Report an error
Infivision
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
China
IIa
MDR
Website
EUDAMED record
Report an error
Isko
Türkiye
I, IIa
MDR
EUDAMED record
Report an error
Iskramedical FDA
Slovenia
IIa, IIb
MDR, 93/42
Website
EUDAMED record
Report an error
JFA Medical
EU representative : CMC Medical Devices & Drugs SL (Spain)
United Kingdom (ex Northern Ireland)
I
MDR
Website
admin01@jfamedical.co.uk
EUDAMED record
Report an error
KMS Kirchensaller Maschinenbau Schaser
Germany
I
MDR
Website
info@spinefit.de
EUDAMED record
Report an error
Korust
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Laserneedle
Germany
IIa
93/42
Website
info@laserneedle.eu
EUDAMED record
Report an error
Lauschaer Glas
Germany
I
MDR
Website
contact@lauschaerglas.de
EUDAMED record
Report an error
Ledfix Elektronik Ticaret Anonim Sirketi
Türkiye
IIa
MDR
EUDAMED record
Report an error
Luxomed
France
IIa
93/42
EUDAMED record
Report an error
Magstim FDA
EU representative : Technomed Europe (Netherlands)
United Kingdom (ex Northern Ireland)
I
MDR
Website
regulatorymagstim@welcony.com
EUDAMED record
Report an error
Mantis
Italy
IIa, IIb
93/42
EUDAMED record
Report an error
Maximus s.c. Robert Klejdysz, Alicja Daniecka-Klejdysz
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Medical Quant
EU representative : Obelis s.a. (Belgium)
Israel
IIa
93/42
info@medical-quant.com
EUDAMED record
Report an error
Medplus
Poland
I
MDR
Website
EUDAMED record
Report an error
Minato Medical Science Kobe Facility
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Japan
IIa
MDR, 93/42
Website
qa-ra@minato-med.co.jp
EUDAMED record
Report an error
Mkb Medical System
Romania
I
MDR
office@mkb-system.ro
EUDAMED record
Report an error
Motek Medical FDA
Netherlands
I
MDR
Website
EUDAMED record
Report an error
MR
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
Website
info@mrev.co.kr
EUDAMED record
Report an error
Myodev
France
I
MDR
Website
contact@myodev.com
EUDAMED record
Report an error
Neo G FDA
EU representative : European Healthcare & Device Solutions Ltd. (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@neo-g.co.uk
EUDAMED record
Report an error
New Age Italia
Italy
IIa
93/42
EUDAMED record
Report an error
novel FDA
Germany
I
MDR
Website
info@novel.de
EUDAMED record
Report an error
Nysale
EU representative : Global E-commerce Experts Europe BV (Netherlands)
United States
IIa
MDR
EUDAMED record
Report an error
Origene
Netherlands
I
MDR
Website
info@origene.nl
EUDAMED record
Report an error
P&S Robotics FDA
EU representative : Arazy Group GmbH (Germany)
South Korea
IIa
MDR
Website
servicekr@walkbot.co.kr
EUDAMED record
Report an error
Photon 4 Health
Netherlands
I
MDR
Website
info@photon4health.com
EUDAMED record
Report an error
Remed FDA
EU representative : Obelis s.a. (Belgium)
South Korea
IIa
MDR
EUDAMED record
Report an error
Saalmann medical FDA
Germany
I, IIa
MDR
Website
info@saalmann-medical.de
EUDAMED record
Report an error
Schneider Medical
Germany
I
MDR
Website
hello@schneider-medical.com
EUDAMED record
Report an error
Shandong Huamei Technology FDA
EU representative : Tech4beauty GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Shanghai SiYi Intelligent Technology FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
Info@siyizn.com
EUDAMED record
Report an error
Sissel
Germany
I
MDR
Website
info@sissel.de
EUDAMED record
Report an error
Solutions
Netherlands
I
MDR
Website
EUDAMED record
Report an error
SportMed
Luxembourg
I
MDR
Website
info@mobee.eu
EUDAMED record
Report an error
Succio Federico
Italy
I
MDR
Website
info@spacewheel.it
EUDAMED record
Report an error
Summus Medical Laser FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIb
93/42
Website
EUDAMED record
Report an error
Syrma Johari MedTech FDA
EU representative : Obelis s.a. (Belgium)
India
IIa
93/42
Website
EUDAMED record
Report an error
Taizhou Branch of Shanghai Yingdu Industry
EU representative : Prolinx GmbH (Germany)
China
IIa
93/42
EUDAMED record
Report an error
Ticmed
Germany
I
MDR
Website
info@ticmed.de
EUDAMED record
Report an error
TOP-RANK Health Care FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
I
MDR
EUDAMED record
Report an error
Vandermeer
Italy
I
MDR
Website
EUDAMED record
Report an error
Wellcomet
Germany
IIa
MDR
Website
PRRC@wellcomet.de
EUDAMED record
Report an error
Won Tech FDA
EU representative : mdi Europa GmbH (Germany)
South Korea
IIa, IIb
93/42
Website
EUDAMED record
Report an error
Wuxi Jiajian Medical Instrument FDA
EU representative : Caretechion GmbH (Germany)
China
IIa
MDR
Website
EUDAMED record
Report an error
Yongkang Jinkang Health Equipment Factory FDA
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
sales02@chinajinkang.com
EUDAMED record
Report an error
Yrobot
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Respironics FDA
EU representative : Respironics Deutschland GmbH & Co.KG (Germany)
United States
12 others Philips NightBalance Mobile App, iOS 93/42 (no longer marketed) Philips NightBalance NL 93/42 (no longer marketed) Philips NightBalance UK 93/42 (no longer marketed) Philips NightBalance, DE 93/42 (no longer marketed) Philips NightBalance, FR 93/42 (no longer marketed) Philips NightBalance, IB 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, Canada 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, DE 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, FR 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, NL 93/42 (no longer marketed) Philips NightBalance, Refurbishment Kit, UK 93/42 (no longer marketed) Philips NightBalance,Refurbishment Kit,IB 93/42 (no longer marketed)
IIa
93/42
eudamed@philips.com
EUDAMED record
Report an error
Gn Med
Italy
1 other
IIb
MDR, 93/42
Website
EUDAMED record
Report an error
Electronique Du Mazet FDA
France
I, IIa
MDR
contact@electroniquedumazet.com
EUDAMED record
Report an error
Shenzhen Konmed Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Syntechlaser FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
IIb
93/42
Website
sales@syntechlaser.com
EUDAMED record
Report an error
3F-Fit Fabricando Faber d.o.o. Beograd-Čukarica
Serbia
IIa
MDR
Website
EUDAMED record
Report an error
6D Tape
Finland
I
MDR
Website
EUDAMED record
Report an error
ActivInsights FDA
EU representative : CEpartner4U (Netherlands)
United Kingdom (ex Northern Ireland)
I
93/42
Website
EUDAMED record
Report an error
Agu-punt FDA
Spain
IIa
MDR
EUDAMED record
Report an error
Albertnovosino FDA
EU representative : Sungo Cert GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Allcare Innovations FDA
France
I
MDR
Website
contact@allcare-in.com
EUDAMED record
Report an error
Alrenas
Türkiye
I
MDR
Website
info@alrenas.com
EUDAMED record
Report an error
Amcube
France
I
MDR
Website
EUDAMED record
Report an error
Amelmedical
Italy
IIa
93/42
EUDAMED record
Report an error
Ampcarellc FDA
EU representative : Obelis s.a. (Belgium)
United States
IIa
MDR
Website
info@ampcarellc.com
EUDAMED record
Report an error
Andent
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
Website
info@andent.cn
EUDAMED record
Report an error
Aneuvo FDA
EU representative : Obelis s.a. (Belgium)
United States
IIb
MDR
Website
regulatory.affairs@aneuvo.com
EUDAMED record
Report an error
APK Technology FDA
EU representative : Ruiyi Healthcare GmbH (Germany)
China
I
MDR
Website
info@apk-technology.com
EUDAMED record
Report an error
Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş San Diş Ti̇c Şti̇
Türkiye
I
MDR
EUDAMED record
Report an error
Ardenne
Germany
IIa
MDR
Website
info@ardenne.de
EUDAMED record
Report an error
Articares FDA
EU representative : QAdvis EAR AB (Sweden)
Singapore
IIa
MDR, 93/42
Website
qa@articares.com
EUDAMED record
Report an error
Aspensurgical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
MDR
Website
customerservice@aspensurgical.com
EUDAMED record
Report an error
Axomove
France
I
MDR
info@axomove.com
EUDAMED record
Report an error
B.A.C
Italy
I
MDR
Website
info@bactechnology.it
EUDAMED record
Report an error
Bark
EU representative : Obelis s.a. (Belgium)
Singapore
IIa
MDR
Website
EUDAMED record
Report an error
Beijing Anchorfree Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
93/42
EUDAMED record
Report an error
Beijing Siriusmed Medical Device
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
93/42
service@siriusmedica.com
EUDAMED record
Report an error
Beijing Stelle Laser Technology FDA
EU representative : MedPath GmbH (Germany)
China
IIb
93/42
EUDAMED record
Report an error
Bertram
Germany
I
MDR
Website
info@bertram.de
EUDAMED record
Report an error
Bio Brem
EU representative : Azienda Tecnica S.r.l. (Italy)
Switzerland
IIa
MDR
info@biobrem.com
EUDAMED record
Report an error
Biogenesys
Italy
IIa
93/42
Website
info@biogenesys.it
EUDAMED record
Report an error
Biotec FDA
Italy
IIb
93/42
info@biotecitalia.com
EUDAMED record
Report an error
Biotechnovations
Italy
I
MDR
info@biotechnovations.com
EUDAMED record
Report an error
BRH medical FDA
EU representative : Arazy Group (Ireland) Ltd. (Ireland)
Israel
IIa
93/42
Website
info@brhmedical.com
EUDAMED record
Report an error
C-Pro Direct FDA
EU representative : C-Pro Direct Ireland Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
enquiries@c-prodirect.com
EUDAMED record
Report an error
Calvo Izquierdo
Spain
I
MDR
Website
admin@calvoizquierdo.es
EUDAMED record
Report an error
Captiks
Italy
I
MDR
info@captiks.com
EUDAMED record
Report an error
Cardiawave
France
IIb
MDR
Website
contact@cardiawave.com
EUDAMED record
Report an error
Carima Solutions
Spain
I
MDR
Website
info@carimatech.com
EUDAMED record
Report an error
Cavallarosrl
Italy
I
MDR
Website
EUDAMED record
Report an error
Centro de Tecnología Biomédica - UPM
Spain
IIa
MDR
EUDAMED record
Report an error
Changzhou Wenyu Medical Instruments FDA
EU representative : Humiss Beratung GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Chaoyangmedical
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
sales01@chaoyangmedical.cn
EUDAMED record
Report an error
Chungwoo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
93/42
EUDAMED record
Report an error
Cleanhearing
Austria
IIa
93/42
Website
EUDAMED record
Report an error
ClearLake-Tech FDA
EU representative : MDSS GmbH (Germany)
United States
I
MDR
Website
info@clearlake-tech.com
EUDAMED record
Report an error
Control Bionics FDA
EU representative : Compliance Management Solutions Europe LTD (Bulgaria)
United States
I
MDR
EUDAMED record
Report an error
CranioMandibular Rehab FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
I
MDR
Website
support@craniorehab.com
EUDAMED record
Report an error
Cynteract
Germany
I
MDR
Website
info@cynteract.com
EUDAMED record
Report an error
Daejumedi FDA
EU representative : Javitech Consulting GmbH (Germany)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Dalian Labtek Science & Development FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Dalla Valle Andrea
Italy
I
MDR
EUDAMED record
Report an error
Dam FDA
Italy
IIa
93/42
Website
info@saunaitalia.com
EUDAMED record
Report an error
Delsys FDA
EU representative : CS Life Sciences Europe Ltd (Ireland)
United States
I
MDR
Website
quality@delsys.com
EUDAMED record
Report an error
Dfmedica
Italy
I
MDR
Website
EUDAMED record
Report an error
Dimedlaser FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIb
MDR
EUDAMED record
Report an error
Dongjilian FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
sales9@dongjilian.com
EUDAMED record
Report an error
Dpemed FDA
EU representative : Obelis s.a. (Belgium)
Israel
I
MDR
Website
info@dpemed.com
EUDAMED record
Report an error
Drsapporo
Poland
I
MDR
Website
EUDAMED record
Report an error
Dynamic Metrics
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
I
93/42
Website
contact@dynamicmetrics.com
EUDAMED record
Report an error
Effectum Medical
EU representative : MED-RAS GmbH Regulatory Affairs Service (Germany)
Switzerland
IIa
MDR
Website
info@effectummedical.com
EUDAMED record
Report an error
Elemenic FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Elmac Elettronica FDA
Italy
IIb
93/42
info@elmaelettronica.com
EUDAMED record
Report an error
Elmed Elektronik Ve Medikal San Tic
Türkiye
IIa
93/42
Website
EUDAMED record
Report an error
Elosan
EU representative : Elosan GmbH (Liechtenstein)
Switzerland
IIa
MDR
Website
info@elosan.com
EUDAMED record
Report an error
emotion fitness
Germany
IIa
MDR
Website
info@emotion-fitness.de
EUDAMED record
Report an error
Erchonia FDA
EU representative : Advena Limited (Malta)
United States
IIa
MDR
EUDAMED record
Report an error
ETT
Italy
I
MDR
Website
EUDAMED record
Report an error
Eunsung Global FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIb
MDR
Website
EUDAMED record
Report an error
Eversion
Germany
I
MDR
Website
EUDAMED record
Report an error
Exxentric
Sweden
I
MDR
Website
info@exxentric.com
EUDAMED record
Report an error
F&B International
Italy
IIa
MDR
EUDAMED record
Report an error
Feetme
France
I
93/42
Website
contact@feetme.fr
EUDAMED record
Report an error
Fidia Farmaceutici FDA
Italy
IIb
93/42
Website
EUDAMED record
Report an error
Firstar FDA
EU representative : MedPath GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Fisiotech
Italy
I
MDR
Website
info@fisiotech.com
EUDAMED record
Report an error
Focusmed
Italy
IIb
MDR
Website
admin@focusmed.it
EUDAMED record
Report an error
Fort Metal Plastic Products Huizhou
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Fortuna Healthcare
EU representative : Fortuna Healthcare (Ireland) Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@fortunahealthcare.eu
EUDAMED record
Report an error
Foshan Gaunying Electronics FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
IIa
MDR
EUDAMED record
Report an error
Foshan Huafukang Medical Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Fotona FDA
Slovenia
IIa
MDR
info@fotona.com
EUDAMED record
Report an error
Fysiomed
Belgium
IIa
93/42
Website
info@fysiomed.com
EUDAMED record
Report an error
GAUKE Healthcare FDA
EU representative : MedPath GmbH (Germany)
China
IIa
MDR
Website
info@gaukefirstaidkit.com
EUDAMED record
Report an error
Glaswarenfabrik Karl Hecht
Germany
I
MDR
Website
EUDAMED record
Report an error
Goang Hann Enterprise FDA
EU representative : MedNet EC-REP GmbH (Germany)
Taiwan
I
MDR
EUDAMED record
Report an error
Gocengmed
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
Godius
EU representative : Emergo Europe B.V. (Netherlands)
South Korea
IIb
MDR
EUDAMED record
Report an error
Gtec FDA
Austria
IIa
MDR
Website
EUDAMED record
Report an error
Guangzhou Qiushi Medical Equipment
EU representative : HUMISS TRADING S. L. (Spain)
China
I
MDR
EUDAMED record
Report an error
Guilin Woodpecker Medical Instrument FDA
EU representative : MedNet EC-REP GmbH (Germany)
China
Piezo Bone Surgery Surgery-X,Surgery-X LED,Surgic Touch LED,Surgic Touch,US-II,DS-II,ULTRASURGERY,US-II LED,DS-II LED,Ultrasurgery LED, 93/42
IIa
93/42
Website
sales@glwoodpecker.com
EUDAMED record
Report an error
Gym80
Germany
I
MDR
Website
EUDAMED record
Report an error
Hankamp Rehab
Netherlands
I
MDR
Website
EUDAMED record
Report an error
Hansol Medical FDA
EU representative : Meridius Medical Europe Limited (Ireland)
South Korea
I
MDR
Website
EUDAMED record
Report an error
Hapticlink
Netherlands
I
MDR
info@hapticlink.nl
EUDAMED record
Report an error
Hash-Tech
Germany
I
MDR
Website
EUDAMED record
Report an error
Healthplussh
EU representative : Everbiz GmbH (Germany)
China
I
MDR
sales@healthplussh.com
EUDAMED record
Report an error
Hearthpilates
Italy
I
MDR
EUDAMED record
Report an error
Heltschl
Austria
IIa
93/42
Website
office@heltschl.at
EUDAMED record
Report an error
Hidrex FDA
Germany
IIa
93/42
Website
info@hidrex.de
EUDAMED record
Report an error
Hidroxa FDA
Sweden
IIa
MDR
Website
EUDAMED record
Report an error
Hopebotics
EU representative : MedNet EC-REP GmbH (Germany)
Hong Kong SAR China
I
MDR
Website
info@hopebotics.org
EUDAMED record
Report an error
Hunan Jianyuan Medical Science Technology FDA
EU representative : Caretechion GmbH (Germany)
China
I
MDR
EUDAMED record
Report an error
Hydas
Germany
I
MDR
Website
eudamed@hydas.de
EUDAMED record
Report an error
Hygenic FDA
EU representative : AR Experts B.V. (Netherlands)
United States
I
MDR
EUDAMED record
Report an error
Icutech
Poland
IIa
MDR
Website
info@icutech.pl
EUDAMED record
Report an error
Identites
France
I
MDR
Website
serviceclient@identites.tm.fr
EUDAMED record
Report an error
Idiag
EU representative : Idiag GmbH (Germany)
Switzerland
I
MDR
Website
info@idiag.ch
EUDAMED record
Report an error
Idrom LT
Spain
IIb
93/42
Website
info@idromgroup.com
EUDAMED record
Report an error
Imp - Piezotehnologija Doo Beograd
EU representative : Salus Cons Kft. (Hungary)
Serbia
IIa
93/42
Website
info@magnetipupin.com
EUDAMED record
Report an error
intelligent motion
Austria
IIa
93/42
info@intelligentmotion.at
EUDAMED record
Report an error
Jindřich Bureš
Czechia
I
MDR
Website
EUDAMED record
Report an error
Jlb France
France
IIa
MDR
info@g5concept.com
EUDAMED record
Report an error
Kinexcs FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
Singapore
I
MDR
Website
info@kinexcs.com
EUDAMED record
Report an error
KP Medical
EU representative : SMEDTEC OÜ (Estonia)
United Kingdom (ex Northern Ireland)
I
MDR
Website
regulatory@zimadental.co.uk
EUDAMED record
Report an error
Lambda Health System
EU representative : Veranex Germany GmbH (Germany)
Switzerland
IIa
MDR
Website
info@lhs-sa.ch
EUDAMED record
Report an error
Lbenergia
Poland
IIa
93/42
EUDAMED record
Report an error
Leaflife FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
Report an error
Lifescience-Robotics
Denmark
IIa
MDR
Website
info@lifescience-robotics.com
EUDAMED record
Report an error
LIME medical
Germany
IIa
MDR
info@lime-medical.de
EUDAMED record
Report an error
Linova-X Tech
EU representative : Lotus NL B.V. (Netherlands)
China
IIa
MDR
EUDAMED record
Report an error
LymphaTouch FDA
Finland
IIa
93/42
contact@lymphatouch.com
EUDAMED record
Report an error
Maokangmedical FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
Report an error
MaRhyThe Systems
Germany
IIa
93/42
Website
info@marhythe-systems.de
EUDAMED record
Report an error
Materialise FDA
Belgium
I
MDR
info.motion@materialise.be
EUDAMED record
Report an error
McRoberts FDA
Netherlands
I
MDR
Website
info@mcroberts.nl
EUDAMED record
Report an error
Mdh
Poland
I
MDR
Website
EUDAMED record
Report an error
MEDEL Medizinische Elektronik Handelsgesellschaft mbH
Germany
IIa
MDR
Website
info@medel-hamburg.de
EUDAMED record
Report an error
Medequip FDA
EU representative : AF Pharma Service Europe SL (Spain)
India
I
MDR
EUDAMED record
Report an error
Medhealth FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
93/42
Website
EUDAMED record
Report an error
Medical Devices Technology International
EU representative : MDTi Cyprus Ltd (Cyprus)
United Kingdom (ex Northern Ireland)
I
MDR
Website
info@mdti.co.uk
EUDAMED record
Report an error
Medihightec
EU representative : MDSS GmbH (Germany)
Taiwan
IIa
93/42
Website
sales@medihightec.com
EUDAMED record
Report an error
Medinice FDA
Poland
IIa
MDR
Website
EUDAMED record
Report an error
Medisport
Italy
IIa
MDR
Website
info@medisport.it
EUDAMED record
Report an error
Medizintechnik Behounek
Austria
IIa
MDR
Website
EUDAMED record
Report an error
Medlander FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Meloq FDA
Sweden
I
MDR
Website
info@meloq.se
EUDAMED record
Report an error
mHealth Technologies
Italy
I
MDR
Website
EUDAMED record
Report an error
Micro Current Technology FDA
EU representative : BEXPERTISE SOLUTIONS, S.L. (Spain)
United States
IIa
MDR
EUDAMED record
Report an error
Microgate
Italy
I
MDR
Website
info@microgate.it
EUDAMED record
Report an error
Minel
Hungary
I
MDR
Website
EUDAMED record
Report an error
Modus Health FDA
EU representative : Advena Limited (Malta)
United States
I
MDR
Website
quality@modushealth.com
EUDAMED record
Report an error
Mtrplus
Germany
IIa
MDR
Website
info@mtrplus.com
EUDAMED record
Report an error
Neurostimulation Medtech FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
India
IIa
MDR
Website
EUDAMED record
Report an error
NM Stahlgeräte
Germany
IIa
MDR
Website
info@nm-stahlgeraete.com
EUDAMED record
Report an error
Noraxon FDA
EU representative : Advena Limited (Malta)
United States
I
MDR
Website
EUDAMED record
Report an error
Nordic-NeuroSTIM
Denmark
I
MDR
Website
info@nordicneurostim.com
EUDAMED record
Report an error
North Coast Medical FDA
EU representative : ICON (LR) Limited (Ireland)
United States
I
MDR
Website
quality@ncmedical.com
EUDAMED record
Report an error
Nuga Medical FDA
EU representative : KTR Europe GmbH (Germany)
South Korea
IIa
93/42
Website
EUDAMED record
Report an error
Nuovotherapy
Slovakia
I
MDR
Website
info@nuovotherapy.cz
EUDAMED record
Report an error
Offhealth
Italy
IIa
93/42
Website
info@offhealth.it
EUDAMED record
Report an error
OOley Care
EU representative : Lotus NL B.V. (Netherlands)
Hong Kong SAR China
I
MDR
info@ooleycare.com
EUDAMED record
Report an error
Oomi
EU representative : Iyashi Dôme (France)
Switzerland
I
93/42
Website
EUDAMED record
Report an error
OOO NPF "Rehabilitation technologies"
EU representative : CEpartner4U (Netherlands)
Russia
I
MDR
Website
info@madin.ru
EUDAMED record
Report an error
OPED FDA
Germany
IIa
MDR
info@oped.de
EUDAMED record
Report an error
Orfit FDA
Belgium
I
MDR
Website
EUDAMED record
Report an error
Ortopedinen Osteopaatti T.Rantala ky
Finland
I
MDR
EUDAMED record
Report an error
Oska FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
IIa
93/42
Website
regulatory@oskawellness.com
EUDAMED record
Report an error
Otivio
Norway
IIa
MDR
Website
info@otivio.com
EUDAMED record
Report an error
Phoenix Innovative Healthcare Manufacturers FDA
EU representative : Advena Limited (Malta)
India
I
MDR
EUDAMED record
Report an error
Physio Börse
Germany
I
MDR
info@physio-boerse.de
EUDAMED record
Report an error
Pneumed
Germany
IIa
93/42
Website
info@pneumed.de
EUDAMED record
Report an error
Pointpressure
Italy
I
MDR
EUDAMED record
Report an error
Polymorit
EU representative : Eurolink Europe Compliance Limited (Ireland)
United Kingdom (ex Northern Ireland)
I
MDR
Website
sales@polymorit.com
EUDAMED record
Report an error
Qolight FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
IIa
MDR
EUDAMED record
Report an error
Rehab-Robotics FDA
EU representative : MedNet EC-REP GmbH (Germany)
Hong Kong SAR China
IIa
MDR
Website
EUDAMED record
Report an error
Rehamedi
Germany
I
MDR
Website
info@rehamedi.de
EUDAMED record
Report an error
Relegs
Netherlands
IIa
93/42
Website
support@relegs.com
EUDAMED record
Report an error
Renew Group FDA
EU representative : Renew Health Ltd. (Ireland)
Singapore
IIa
MDR
Website
contactus@renewgpl.com
EUDAMED record
Report an error
Resla
Germany
I
MDR
EUDAMED record
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Rk Innov
France
IIa
MDR
contact@rkinnov.fr
EUDAMED record
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Rossiello Angelo
Italy
IIa
93/42
info@evolutamente.it
EUDAMED record
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Sabora
Finland
I
93/42
Website
info@sabora.fi
EUDAMED record
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Sanctuaryhealth FDA
EU representative : Wellkang Ltd (Northern Ireland)
Malaysia
I
MDR
Website
info@sanctuaryhealth.com.my
EUDAMED record
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Satisform
France
I
MDR
Website
admin@satisform.com
EUDAMED record
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Savir
Germany
IIa
93/42
Website
regulatory@savir-center.com
EUDAMED record
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Sense4Care
Spain
IIa
MDR
Website
info@sense4care.com
EUDAMED record
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Sfsolutions
Poland
I
MDR
Website
EUDAMED record
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Shenzhen Aeon Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIa
MDR
Website
EUDAMED record
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Shenzhen OSTO Medical Technology FDA
EU representative : phoenix Medtech GmbH (Germany)
China
IIa
MDR
Website
sales06@szosto.com
EUDAMED record
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Shenzhen Tianjiquan Health Science & Technology Group
EU representative : BioDomi GmbH (Germany)
China
IIa
93/42
Website
EUDAMED record
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Shunmei Medical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
IIb
MDR
EUDAMED record
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Sofwave FDA
EU representative : Obelis s.a. (Belgium)
Israel
IIa
93/42
Website
support@sofwave.com
EUDAMED record
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Solsius
France
I
MDR
admin@solsius.fr
EUDAMED record
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Stendo
France
IIa
MDR
contact@stendo.net
EUDAMED record
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Storz Medical FDA
EU representative : STORZ MEDICAL Deutschland GmbH (Germany)
Switzerland
IIa
93/42
Website
info@storzmedical.com
EUDAMED record
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Stratec Medizintechnik FDA
Germany
I
MDR
info@stratec-med.com
EUDAMED record
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Sucesores De Manuel García
Spain
I
MDR
Website
EUDAMED record
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Sunstar FDA
EU representative : Sunstar France (France)
Switzerland
IIa
93/42
Website
regulatory@ch.sunstar.com
EUDAMED record
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Surgnova FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
IIb
MDR
qara@surgnova.com
EUDAMED record
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Swissbionic
Switzerland
IIa
MDR
Website
EUDAMED record
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Talley Group FDA
EU representative : Advena Limited (Malta)
United Kingdom (ex Northern Ireland)
IIa
MDR
EUDAMED record
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Tao Technologies società a responsabilità limitata semplificata
Italy
I
MDR
Website
EUDAMED record
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Tediro
Germany
I
MDR
Website
service@tediro.com
EUDAMED record
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Tekscan FDA
EU representative : WMDE B.V. (Netherlands)
United States
I
MDR
EUDAMED record
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Telmed
Germany
IIa
MDR
EUDAMED record
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Thorsis
Germany
I
MDR
Website
info@thorsis.com
EUDAMED record
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Top Sale Spółka z ograniczoną odpowiedzialnością
Poland
I
MDR
info@bocioland.pl
EUDAMED record
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Totalgym
EU representative : Total Gym Europe B.V. (Netherlands)
United States
I
MDR
Website
EUDAMED record
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Turkuazsaglik
Türkiye
I
MDR
Website
info@turkuazsaglik.com.tr
EUDAMED record
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Tyromotion FDA
Austria
IIa
MDR
regulatoryaffairs@tyromotion.com
EUDAMED record
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UAB Kasko Group
Lithuania
I
MDR
Website
EUDAMED record
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United Pacific Industries Pty FDA
EU representative : Advena Limited (Malta)
Australia
I
MDR
Website
enquiries@upi.com.au
EUDAMED record
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Universal Pain Technology Canada FDA
EU representative : AR Experts B.V. (Netherlands)
Canada
IIa
MDR
Website
info@spinemed.com
EUDAMED record
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Vicon FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
I
93/42
Website
info@vicon.com
EUDAMED record
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Vissco
EU representative : AF Pharma Service Europe SL (Spain)
India
I
MDR
EUDAMED record
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Vulpés Electronics
Germany
I
MDR
Website
info@vulpes-electronics.com
EUDAMED record
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Werunia
Germany
I
MDR
info@werunia.de
EUDAMED record
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Winncare FDA
Denmark
I
MDR
Website
info@ergolet.dk
EUDAMED record
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Withings FDA
France
IIa
MDR
Website
regulatory@withings.com
EUDAMED record
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Wonder
Germany
I
MDR
Website
mail@wonder.gmbh
EUDAMED record
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Yiwu City Ange Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Youjiuhealth
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Yufo Biotech
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
support@xjwondfo.com.cn
EUDAMED record
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Zehnit
EU representative : Lotus NL B.V. (Netherlands)
China
I
MDR
Website
info@zehnit.cn
EUDAMED record
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Zhaoqing Yingguang Maoyi Youxian gongsi
EU representative : Everbiz GmbH (Germany)
China
I
MDR
EUDAMED record
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Zhejiang Unsurpassed Industry Trade
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Zhenjiang Rapid Rehab & Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Özden Tip Tibbi̇ Ci̇haz Ve Malzemeler Gida Teksti̇l Ti̇c Şti̇
Türkiye
I
MDR
info@ozdentip.com
EUDAMED record
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Meditech International FDA
EU representative : Obelis s.a. (Belgium)
No model still on the market
Canada
5 others
IIa, IIb
93/42
Website
regulatory@bioflexlaser.com
EUDAMED record
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Novin Electronics & Electrical Industries Engineering
EU representative : Obelis s.a. (Belgium)
No model still on the market
Iran
IIa, IIb
93/42
Website
EUDAMED record
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1M4
No model still on the market
Estonia
I
MDR
Website
info@1m4.eu
EUDAMED record
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Ascent Meditech
EU representative : Mars Medical (Germany)
No model still on the market
India
I
MDR
Website
regulatory@ascentmeditech.com
EUDAMED record
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Focus Surgery
EU representative : CEpartner4U (Netherlands)
No model still on the market
United States
IIb
93/42
info@sonablate.com
EUDAMED record
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Indiba FDA
No model still on the market
Spain
IIa
MDR
Website
regulatory@indiba.com
EUDAMED record
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Lutronic FDA
EU representative : Emergo Europe B.V. (Netherlands)
No model still on the market
South Korea
IIa
93/42
EUDAMED record
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Mcubetech FDA
EU representative : AR Experts B.V. (Netherlands)
No model still on the market
South Korea
IIa
93/42
EUDAMED record
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