External prostheses and orthosesUpper extremity orthoses (splints and braces)

Orthoses, upper extremity - other

EMDN code Y060699

76 manufacturers, 200 models including 193 on the market, 23 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 76

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Villa Manus	Finland	Fleecepehmuste 45 x 30 cm, 4kpl/pkt,Harmaa Fleecepehmuste 45 x 30 cm, 4kpl/pkt,Tummansininen Fleecepehmuste 45 x 30 cm, 4kpl/pkt,Vaaleansininen Fleecepehmuste 45 x 30 cm, 4kpl/pkt,Valkoinen Fleecepehmuste 45 x 30 cm, 4kpl/pkt,Viininpunainen 28 others Villa Manus -fleece kapea 8 cm x 546 cm tummansininen Villa Manus College Musta 20 x 30 cm Villa Manus College Tummansininen 20 x 30 cm Villa Manus College Vanha roosa 20 x 30 cm Villa Manus Fleece Harmaa 20 x 30 cm Villa Manus Fleece Pinkki 20 x 30 cm Villa Manus Fleece Punainen 20 x 30 cm Villa Manus Fleece Tummansininen 20 x 30 cm Villa Manus Fleece Vaaleansininen 20 x 30 cm Villa Manus Fleece Valkoinen 20 x 30 cm Villa Manus Fleece Vihreä 20 x 30 cm Villa Manus Fleece Viininpunainen 20 x 30 cm Villa Manus Fleece Violetti 20 x 30 cm Villa Manus Fleece Värivalikoima 20 x 30 cm Villa Manus Kokeilupakkaus, yhteensä 4 levyä 20 x 30 cm Villa Manus Ohut kuviollinen fleece 20 x 30 cm vaihtuva kuvio Villa Manus Ohut puuvillafleece Keltainen 20 x 30 cm Villa Manus Ohut puuvillafleece Kitti 20 x 30 cm Villa Manus Ohut puuvillafleece Musta 20 x 30 cm Villa Manus Ohut puuvillafleece Pinkki 20 x 30 cm Villa Manus Ohut puuvillafleece Turkoosi 20 x 30 cm Villa Manus Ohut puuvillafleece Viininpunainen 20 x 30 cm Villa Manus Ohut puuvillafleece Värisekoitus 20 x 30 cm Villa Manus ‐pehmusteet College Sinisavu 20 x 30 cm Villa Manus ‐pehmusteet College Syreenin lila 20 x 30 cm Villa Manus ‐pehmusteet College Viininpunainen 20 x 30 cm Villa Manus ‐pehmusteet Velvet Tummansininen 20 x 30 cm Villa Manus ‐pehmusteet Velvet Viininpunainen 20 x 30 cm	I MDR	Website info@villamanus.com EUDAMED record Report an error
Mediroyal	Sweden	ARX® Spacer Fabric 4mm 58x100cm EU4905002 refs I-ARX® Inner Lining 58cm x 100cm EU4581012 refs Neoprene Black Nylon/Black Nylon 1mm 125x100cm EU4902013 refs Neoprene Black Nylon/Black Nylon 3mm 125x100cm EU4902033 refs Neoprene Black Nylon/Black Nylon 5mm 125x318cm EU4902052 refs 18 others Neoprene OP loop /Black Nylon 1mm 125x318cm EU4901012 refs Neoprene OP loop /Black Nylon 3mm 125x318cm EU4901032 refs Neoprene OP loop /Black Nylon 5mm 125x318cm EU4901052 refs Neoprene Royal Blue/Black Nylon 1mm 125x318cm EU4903012 refs Neoprene Royal Blue/Black Nylon 3mm 125x318cm EU4903032 refs Neoprene Royal Blue/Black Nylon 5mm 125x318cm EU4903052 refs Neoprene Sharkskin/Black Nylon 3mm 125x318cm EU4900032 refs Neptune Black Lycra/Neptune Grey width 140cm running meter EU4904042 refs Neptune™ Black OP Loop/Neptune Grey 58x100cm EU4904032 refs NRX® Strap Material 1 mm Black EU446601 NRX® Strap Material 1mm 125x318cm EU446900 NRX® Strap Material 3mm 125x318cm EU4466032 refs NS12_Black OP / Black OP 3mm SCDO103 NS12_Black OP / Black OP 5mm SCDO105 P-ARX® Lining/Neptune™ 3,5mm 125x318cm EU4582022 refs P-ARX® Thin Lining/Neptune™ 1,8mm 58x100cm EU4582012 refs Ventus™ Beige Lycra/Black Fleece 58x100cm EU4904012 refs Ventus™ Black Lycra/Black Fleece 58x100cm EU4904002 refs	I MDR	Website EUDAMED record Report an error
Orfit FDA	Belgium	Aquafit™ NS 45 x 60 cm x 1.6 mm, Micro Perforated, NS Coated Thermoplastic material3 refs Colorfit NS Active Pink 45 x 60 cm x 3.2 mm, Non Perforated, NS Coated Thermoplastic material3 refs Complete Thumb Orthosis - Large - Orfit® Classic 2.0 mm, Micro Perf, Soft Thermoplastic material3 refs Dorsal Wrist Cock-Up Orthosis - Large Orfit® Eco 3.2 mm, Non Perf Thermoplastic material3 refs Gauntlet Immobilization Orthosis - Large, Orfit® Colors NS Atomic Blue 2.0 mm, Micro Perf Thermoplastic material3 refs 8 others Gauntlet Thumb Post Orthosis - Large - Orfilight® Black NS 1.6 mm, Micro Perf Thermoplastic material3 refs Isoforce - Large 1 piece Hardware3 refs Large Orfizip®Light NS Atomic Blue Wrist splint 2.5 mm micro perfo + non-stick antibact. coating Thermoplastic material3 refs Orfibrace™ NS 60 x 90 cm x 3.0 mm, Macro Perforated, NS Coated Thermoplastic material2 refs Orficast® Black Thermoplastic Casting Tape - 1 roll , 3 cm x 3 m Thermoplastic material3 refs Orfit® NS 45 x 60 cm x 1.6 mm Micro Perforated, NS Coated, Soft Thermoplastic material3 refs Tecnofit™ 45 x 60 cm x 2.5 mm Maxi Perforated, NS Coated Thermoplastic material3 refs Water Bath Large - 230 V -1400W - with UK plug3 refs	I MDR	Website EUDAMED record Report an error
Medequip FDA EU representative : AF Pharma Service Europe SL (Spain)	India	Clavicle Brace3 refs Clavicle Brace with Buckle3 refs Ls Belt Contoured3 refs Lumbo Sacral belt3 refs Maternity/Pregnancy Belt3 refs 6 others Pelvic Binder3 refs Posture Corrector3 refs RIB Belt3 refs Sternal Support3 refs Tummy Trimmer3 refs Waist Belt Neoprene	I MDR	EUDAMED record Report an error
DM Orthotics FDA EU representative : MedEnvoy Global BV (Netherlands)	United Kingdom (ex Northern Ireland)	Custom Double Shoulder Stability Orthosis DM 41 Custom Glove/Gauntlet with separate Sleeve DM 16 Custom Glove/Gauntlet with sleeve DM 17 Custom Glove/Gauntlet without Sleeve DM 18 Custom Hand Shoulder Orthosis DM 50 3 others Custom Open Palm Glove DM 49 Custom Single Shoulder Stability Orthosis DM 40 Custom Sleeve without Attachment DM 11	I MDR	Website admin@dmorthotics.com EUDAMED record Report an error
Reh4Mat	Poland	ORTEZA KOŃCZYNY GÓRNEJ FIX-KG-22 ORTEZA KOŃCZYNY GÓRNEJ MASTER-01 ORTREZA KOŃCZYNY GÓRNEJ OKG-223 refs ORTREZA KOŃCZYNY GÓRNEJ OKG-23 ORTREZA KOŃCZYNY GÓRNEJ OKG-242 refs 1 other ORTREZA KOŃCZYNY GÓRNEJ OKG-253 refs	I MDR	Website EUDAMED record Report an error
Medisport	France	Attache-Membres avec Boucle3 refs CEINTURE ABDOMINALE ORTHOMARINE3 refs CEINTURE LOMBAIRE ACTIVE3 refs Ceinture Thoracique Taille 13 refs Corset Imoform Taille 12 refs	I MDR	EUDAMED record Report an error
Sigvaris FDA	Poland	PT 0204 Arm sling, pattern 1, XXS PT 0204 Temblak kończyny górnej3 refs PT 0211 Arm sling with stabilization , L PT 0211 Temblak kończyny górnej ze stabilizacją3 refs PT 0214 Breathable arm sling, L PT 0214 Temblak kończyny górnej siatkowy3 refs PT 0336 Arm sling, green, L PT 0336 Temblak kończyny górnej3 refs PT 0345 Temblak kończyny górnej YOUNG3 refs	I MDR	Website EUDAMED record Report an error
Sober	France	AP/BAR - TU/A ATTELLE DE POIGNET DE SECOURS93/42 ATTELLE DE BRAS SMURFORM ATTELLE DE SECOURS93/42 ATTELLE DE MAIN SMURFORM ATTELLE DE SECOURS93/42 SMUR BRAS ATTELLE DE SMUR93/42 SMUR BRAS RT ATTELLE DE SMUR RADIOTRANSPARENTE93/42	I 93/42	Website EUDAMED record Report an error
SPIO FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	S411 S441 S471 S511	I MDR	Website info@spioworks.com EUDAMED record Report an error
Camp	Sweden	Elements Body Trial Body3 refs Elements Body Trial Body Basko3 refs WRIST STRAP, BLACK	I MDR	Website info@camp.se EUDAMED record Report an error
Shenzhen QiJiang Technology EU representative : REP Europe GmbH (Germany)	China	AS-21，AS-22，AS-23，AS-24，AS-25，AS-26，AS-27，AS-28，AS-29，AS-210，AS-211，AS-212，AS-213，AS-214，AS-215，AS-216，AS-217，AS-218，AS-219，AS-220 HB-210，HP-24，HE-211，HE-213，EB-25，EB-26，EB-27，EB-28，EB-29，EB-210，EB-211，EP-212，EP-213，EP-214，EP-215，EP-216，EP-217，EE-218，EE-219，EE-2202 refs SS-21，SS-22，SS-23，SS-24，SS-25，SS-26，SS-27，SS-28，SS-29，SS-210，SS-211，SS-212，SS-213，SS-214，SS-215，SS-216，SS-217，SS-218，SS-219，SS-220	I MDR	EUDAMED record Report an error
Torosgroup EU representative : Medtex Sp. z o.o. (Poland)	Ukraine	Clavicle Support Brace, Size 1 Type 6533 refs Neoprene Hip Support Brace (Left), Size 1 Type 253L2 refs Neoprene Hip Support Brace (Right), Size 1 Type 253R2 refs	I MDR	Website EUDAMED record Report an error
Algran Manufactura Sanitaria	Spain	CABESTRILLO LONETA VERDE TALLA XL3 refs CABESTRILLO REJILLA BLANCO TALLA L Z10008S3 refs	I MDR	Website EUDAMED record Report an error
Bioaktif	Türkiye	BA 160 P XS / VELPOFIX VELPEAU BANDAGE PEDIATRIC XS3 refs BFC100S-XS / FOAM COMPRESS Foot Sleeve Black XS3 refs	I MDR	Website info@bioaktif.com.tr EUDAMED record Report an error
BioSculptor FDA EU representative : Eurolink Europe Compliance Limited (Ireland)	United States	Maramed Humerus Fracture Brace, Large, Left3 refs Maramed Ulna Fracture Brace, Large, Left3 refs	I MDR	Website EUDAMED record Report an error
Conlett EU representative : Lotus NL B.V. (Netherlands)	China	Bendiboard BB0013 refs Neo-Board NB0013 refs	I MDR	EUDAMED record Report an error
Erhem	Poland	Kamizelka stawu barkowego ERH-343 refs Kamizelka stawu barkowego ERH-34 XL93/42	I MDR, 93/42	Website EUDAMED record Report an error
Fortune FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	A01-S2,A01-L2,A02-SM,A02-MD,A02-LG,A02-XL,A03b-S2,A03b-L2,A04-UN,A06-UN,A08-UN,A08-SM,A08-MD,A08-LG,A09-UN,A09-S2,A09-L2,A10-UN,A11-SM-LT,A11-MD-LT,A11-LG-LT,A11-XL-LT,A11-SM-RT,A11-MD-RT,A11-LG-RT,A11-XL-RT, etc.3 refs E02-UN,E03-UN,E05-SM,E05-MD,E05-LG,E06-UN,E08-UN,E10-UN,E10-SM,E10-MD,E10-LG,E11-UN,E17-UN,E18-UN,E20-UN,E22-UN-LT,E22-UN-RT,E36-UN,E37-UN,E38-UN,W01-UN,W02-UN-LT,W02-UN-RT,W03-SM-LT,W03-MD-LT,W03-LG-LT,W03-SM-RT, etc.3 refs	I MDR	EUDAMED record Report an error
Irufa FDA EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)	Taiwan	Limb Holder Orthopedic Support2 refs Spacer Fabric Wrist Splint Sleeve WR-OS-17 Neoprene3 refs	I MDR	Website EUDAMED record Report an error
Reha Fund	Poland	TEMBLAK KOŃCZYNY GÓRNEJ O-15003 refs TEMBLAK KOŃCZYNY GÓRNEJ SIATKOWY CZARNY O-15013 refs	I MDR	Website EUDAMED record Report an error
Tonuselast	Latvia	Finger splint ELAST 1704 Medicīniskais elastīgais apsējs4 refs	I MDR	Website info@tonuselast.com EUDAMED record Report an error
Myomo FDA EU representative : CS Life Sciences Europe Ltd (Ireland)	United States	MARK2 MyoPro 2+ Motion G Right3 refs Mark93/42 (no longer marketed) MyoPro 2 Motion E Left93/42 (no longer marketed) MyoPro 2 Motion E Right93/42 (no longer marketed) MyoPro 2 Motion G right93/42 (no longer marketed) 2 others MyoPro 2 Motion W Left93/42 (no longer marketed) MyoPro 2 Motion W Right93/42 (no longer marketed)	I MDR, 93/42	Website EUDAMED record Report an error
3M FDA EU representative : 3M Deutschland GmbH (Medical) (Germany)	United States	FUTURO™ Cervial Collar3 refs	I MDR	EUDAMED record Report an error
Achim Ruthner	Germany	Epi-Spange Gr. Large3 refs	I MDR	info@ruthner-gmbh.de EUDAMED record Report an error
Angel Sports-Medical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	KINSTRON	I MDR	info@angelsports-medical.com EUDAMED record Report an error
Anping Guardian Medical Equipment FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Head Immobilizer AZ-HI01、AZ-HI-01、AZ-HI-02、AZ-HI-03、AZ-HI-05、AZ-HIA、AZ-HIA-01、AZ-HIA-02、AZ-HIA-03、AZ-HIA-04、AZ-HIS3 refs	I MDR	Website info@splint.cn EUDAMED record Report an error
Aolikes FDA EU representative : Sungo Cert GmbH (Germany)	China	3101,3103, 3104, 3110, 3112, 3113, 3116, 3117, 3118, 3119 ,OR CUSTOMIZED	I MDR	EUDAMED record Report an error
Arden Medical FDA	Türkiye	Epicare3 refs	I MDR	Website EUDAMED record Report an error
Aries	Czechia	BrownGuard 100 bandáž klavikulární typ 01	I MDR	Website EUDAMED record Report an error
Awatar	Croatia	Awatar AW216	I MDR	info@awatar.hr EUDAMED record Report an error
Beijing Jinwei Kangda Medical Instrument FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	KDWZ-JB-001 KDWZ-ZW-001 KDZJ-JB-002 KDZJ-JB-003 KDZJ-JB-004 KDZJ-JB-008 KDZJ-ZB-001 KDZJ-ZB-002 KDZJ-ZB-003 KDZJ-ZB-004 KDZJ-ZB-005 KDZJ-ZB-006 KDZJ-ZB-007 KDZJ-ZB-008 KDZJ-ZB-009 etc.	I MDR	EUDAMED record Report an error
Bort FDA	Germany	BORT Clavicula-Bandage	I MDR	Website EUDAMED record Report an error
Bosegrow FDA EU representative : HyperCert Limited B.V. (Netherlands)	China	Adjustable ROM Elbow Brace S,M,L,XL,Universal,Left,Right3 refs	I MDR	EUDAMED record Report an error
Cangzhou Xiankang Medical Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	PD-322, PD-323, PD-324, PD-325, PD-326, PD-327, PD-328, PD-329, PD-330, PD-331, PD-332 or customized	I MDR	EUDAMED record Report an error
Cinarmedikal	Türkiye	CLAVICLE BANDAGE ADJUSTABLE L3 refs	I MDR	Website info@cinarmedikal.com EUDAMED record Report an error
Cinfa	Spain	FARMALASTIC CABESTRILLO BANDA UNIVERSAL ADVANCE TECH Talla Única Color Gris	I MDR	Website EUDAMED record Report an error
Cofoe FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Back Brace AP1, U9, BQ1, NL1, NE1, K2, S1, BE1, BU9, B3, B4, B5, B6, B7, C1, C2, C3, C4, C53 refs	I MDR	Website EUDAMED record Report an error
Dorrella EU representative : Sungo Cert GmbH (Germany)	China	CO0001, CO0002, CO0003, CO0004, CO0005	I MDR	EUDAMED record Report an error
Dyno Rechi	Spain	CODERA CORTA NEOPRENO3 refs	I MDR	Website EUDAMED record Report an error
Emsrun FDA EU representative : Sungo Cert GmbH (Germany)	China	Rhino Rescue Flat,Roll,Fold	I MDR	EUDAMED record Report an error
Fgpsrl FDA	Italy	HFB3 refs	I MDR	EUDAMED record Report an error
Foshan Suncare Medical Products FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Finger Supports SC-060,SC-061,SC-062,SC-063,SC-064,SC-065,SC-066,SC-067,SC-068,SC-069,SC-070,SC-071, ect.	I MDR	EUDAMED record Report an error
Gstc FDA EU representative : Obelis s.a. (Belgium)	India	Heuer 22-190	I MDR	Website regulatoryaffairs@gstc.com EUDAMED record Report an error
Guangzhou Renlai Rehabilitation Equipment Manufacturing EU representative : SUNGO Europe B.V. (Netherlands)	China	RLGT501	I MDR	EUDAMED record Report an error
Hangzhou Tuopusi Medical Products FDA EU representative : Caretechion GmbH (Germany)	China	Braces and supports TPS BAS01	I MDR	EUDAMED record Report an error
Hebei Denovo Medical Device EU representative : SUNGO Europe B.V. (Netherlands)	China	Christou1910 CH-009, CH-015, DNOR-W01, DNOR-W02, DNOR-W03, DNOR-W04, DNOR-W05, DNOR-W11, DNOR-W12, DNSP-35, DNSP-36, DNSP-37, DNSP-38	I MDR	EUDAMED record Report an error
Hebei Zhaoyang Medical Instrument EU representative : EUREP ENV, S.L (Spain)	China	Upper Limb Orthoses ZY-AR03(S,M, L, XL, XXL)	I MDR	EUDAMED record Report an error
Heruimedical FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	YHR-F02, YHR-F03, YHR-F04, YHR-F05, YHR-F06, YHR-F07, YHR-F08, YHR-F09, YHR-F10, YHR-ED01, YHR-ED02, YHR-TG1, YHR-TG2	I MDR	EUDAMED record Report an error
Hugh Steeper FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	Adolescent Forearm, 64mm, 50mm Wrist, Dark Brown3 refs	I MDR	Website EUDAMED record Report an error
La Pointique Int´l EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Arm Compression Sleeve 130XT-BK-L3 refs	I MDR	Website EUDAMED record Report an error
Lifelike Prosthetics	Germany	Myra Skin N°13 refs	I MDR	Website info@lifelike-prosthetics.de EUDAMED record Report an error
Lightwing Marketing EU representative : Patient Guard Europe UG (Germany)	United Kingdom (ex Northern Ireland)	Protek 21950	I MDR	Website info@lightwing-marketing.com EUDAMED record Report an error
Linye Health Tech Ningbo EU representative : Sungo Cert GmbH (Germany)	China	ARM STRAP LY-AS00	I MDR	EUDAMED record Report an error
Medi Global Assistive Device EU representative : Humiss International B.V. (Netherlands)	China	8" Padded Wrist Brace Upper Limb Orthoses3 refs	I MDR	Website info@medi-rehatek.com EUDAMED record Report an error
Mtsaglik	Türkiye	Korse Lumbostad 26cm Siyah XXXL	I MDR	Website EUDAMED record Report an error
Ningbo Kangbeien Health Tech EU representative : HyperCert Limited B.V. (Netherlands)	China	Compression Glove；Wrist Support；Finger Support；Elbow Support；Arm Sling；Shoulder Support DG-5170223 refs	I MDR	EUDAMED record Report an error
OPPO Medical FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Taiwan, United States	Arm Immobilizer6 refs	I MDR	Website EUDAMED record Report an error
ORTEX , spol. s r.o	Czechia	ORTEX 012 Ortéza pro fixaci klíční kosti	I MDR	Website EUDAMED record Report an error
Protetika	Slovakia	Gumotextilná bandáž lakťa a predlaktia LA-21 Elbow and forearm orthose4 refs	I MDR	Website EUDAMED record Report an error
Rebole d.o.o	Slovenia	OPORNICA ZA IMOBILIZACIJO UDOV-ROKA 96003 refs	I MDR	EUDAMED record Report an error
Safety	Italy	REGGIBRACCIO	I MDR	Website info@safety.it EUDAMED record Report an error
Sanomed	Czechia	Sanomed 451 - bandáž pro fixaci klíční kosti - L	I MDR	Website info@sanomed.cz EUDAMED record Report an error
Shanae	Spain	INMOVILIZADOR DE CLAVÍCULA, talla 1	I MDR	EUDAMED record Report an error
Sichuan Yangtze River Medical Devices EU representative : MedPath GmbH (Germany)	China	Washable orthopedic cast3 refs	I MDR	EUDAMED record Report an error
Span Link International FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Clavicular Support3 refs	I MDR	EUDAMED record Report an error
Tecnoway	Italy	ORTESI PER OMERO OM1003 refs	I MDR	Website info@tecnoway.it EUDAMED record Report an error
Tim Fit EU representative : SUNGO Europe B.V. (Netherlands)	Hong Kong SAR China	TMRWT1219,TMRWT1220, TMRWT1222, TMRWT1226, TMRWT1227	I MDR	EUDAMED record Report an error
Unitrend FDA EU representative : KOMAS Medical Technology GmbH (Germany)	Taiwan	Upper Extremity RP240	I MDR	EUDAMED record Report an error
Wellempire EU representative : SUNGO Europe B.V. (Netherlands)	China	L2 L2P; F32 refs	I MDR	EUDAMED record Report an error
Welsheng EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Taiwan	Arm Compression Sleeve 130XT-BK-L-13 refs	I MDR	Website EUDAMED record Report an error
Woosam FDA EU representative : AF Pharma Service Europe SL (Spain)	South Korea	THERMOPLASTIC SPLINT3 refs	I MDR	Website EUDAMED record Report an error
Yangzhou Jingba Sports Goods EU representative : Humiss Beratung GmbH (Germany)	China	Leg support 7796,8715,7817,7808,7810,7823,7824,7844,8746,7859,7861，4225,4230,7004,4204,5204,7759,7006,7537,7007,7008,8335,8338,8369，1005,2005,3005,5005,2105,6005,1105,5205,5024,5015,5016,5017,5004,5009,5026,5028 or customized	I MDR	Website EUDAMED record Report an error
Zhejiang Steriger Sports Medicine Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Arm sleeve（SME-02、48724、48725） Wrist support（BDFP-8214、48712、48713、BDFP-10、02578） Elbow support（BDFE-14、46790）etc	I MDR	EUDAMED record Report an error
Össur Iceland ehf	Iceland	Figure-8 Clavicle Splint BU000243 refs	I MDR	info-europe@ossur.com EUDAMED record Report an error
Sporlastic FDA No model still on the market	Germany	NEURO-RESTRICT (no longer marketed)	I MDR	Website info@sporlastic.de EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 335

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
NEOTECH CARE INC. Present in Europe in other categories	–	Neotech Care	registered
MEDI MANUFACTURING, INC.	–	MEDI	registered
VIVE HEALTH LLC Present in Europe in other categories	United States	Vive CoreTech	registered
INDACO SRL	Italy	BEST BACK M-Brace Air	registered
Ideavillage Products Corp	United States	Copperfit	registered
Bird & Cronin, LLC	United States	EXTENSOR LIFTING BELT W/STRAP 2XL EXTENSOR LIFTING BELT W/STRAP XL EXTENSOR LIFTING BELT W/STRAP MD EXTENSOR LIFTING BELT W/STRAP 3XL EXTENSOR LIFTING BELT W/STRAP LG EXTENSOR LIFTING BELT W/STRAP SM	registered
Comfy Health Group Co., Ltd.	Taiwan	ComfyHealth	registered
REABILITIMED TOV	–	TM "Rehabilitimed" I-6M-V M Comfort TM "Rehabilitimed" I-6M-V XXXL Comfort TM "Rehabilitimed" I-6M XXXL Comfort TM "Rehabilitimed" I-6M XS Comfort TM "Rehabilitimed" I-6M S Comfort TM "Rehabilitimed" I-6M L Comfort	registered
Breg, Inc. Present in Europe in other categories	United States	BREG	registered
Nea International B.V. Present in Europe in other categories	Netherlands	Push braces	registered
Boston Brace International, Inc.	United States	Boston Brace Boston Body Jacket, Bivalve Opening Boston Overlap Brace (BOB) Boston Body Jacket, Single Opening	registered
Asp Global, LLC	United States	ASP MEDICAL	registered
BM KOREA CO., LTD	South Korea	Guardian Supporter	registered
Medi-Tech, Inc. Present in Europe in other categories	United States	Medi-Band	registered
TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD. Present in Europe in other categories	China	Tairuibosi	registered
Therafin Corporation	–	Therafit Belts	registered
Hengshui Tianjian Medical Supplies CO.,LTD Present in Europe in other categories	China	ELITE BRITE AZMED	registered
Korea New Tech Co., Ltd.	–	Aroma Sense	registered
Manamed, Inc.	United States	ManaMed Tailback2-64 Tailback 27 Tailback2-42 Three in One Belly Band	registered
Dynarex Corporation	United States	Abdominal Binder	registered
WALGREEN CO.	–	Walgreens	registered
Wuxi Emsrun Technology Co., Ltd.	–	EMSRUN	registered
Comfytopia, Inc.	–	Comfytopia	registered
DJO, LLC	United States	DONJOY PERFORMANCE DONJOY ADVANTAGE	registered
O&M HALYARD, INC.	United States	Halyard	registered
SPENCER ITALIA SRL Present in Europe in other categories	Italy	Spencer	registered
Sevenground Trading B.V.	Netherlands	Keenhealth	registered
Thermor Ltd	Canada	BIOS Living	registered
Unite Medical, LLC	United States	Unite Medical®	registered
Guangzhou Xinbo Electronic Co., Ltd. Present in Europe in other categories	China	DR-HO'S	registered
MEDITRAC LTD. Present in Europe in other categories	–	Vertetrac	registered
ROBUST VENTURES LTD	–	Love Noobs	registered
Resource Optimization & Innovation, L.L.C.	–	Regard™	registered
Shenzhen Konmed Technology Co., Ltd. Present in Europe in other categories	China	Konmed	registered
TRULIFE LIMITED Present in Europe in other categories	Ireland	Trulife	registered
AID UNITED INTERNATIONAL CO., LIMITED Present in Europe in other categories	China	–	registered
ALEX ORTHOPEDIC, INC.	United States	–	registered
ALLMAY INTERNATIONAL LIMITED	Hong Kong SAR China	–	registered
ANJI HUIFENG SURGICAL DRESSINGS CO., LTD.	China	–	registered
ANJI SPENQ INDUSTRIAL CO., LTD.	China	–	registered
ASP Tiger, LLc	United States	–	registered
ASPEN MEDICAL PRODUCTS, LLC Present in Europe in other categories	United States	–	registered
Abletech Orthopedics Corporation	China	–	registered
Ablue Co., Ltd. Present in Europe in other categories	South Korea	–	registered
Accumed Intl., Inc.	United States	–	registered
Actlife Technology Co., Ltd - Thanh Hoa Branch	Vietnam	–	registered
Acute Ideas Co. , Ltd.	Taiwan	–	registered
Airamed GmbH Present in Europe in other categories	Germany	–	registered
Allmay Bodywear (Shenzhen) Co., Ltd	China	–	registered
Alphapointe	United States	–	registered
Altimate Medical, Inc. Present in Europe in other categories	United States	–	registered
Amazing Brace, LLC	United States	–	registered
American Medical Products, Inc.	United States	–	registered
AnHui YiBao Home Textile Co.,Ltd	China	–	registered
Anhui CHR Software Technology Limited Company	China	–	registered
Anping Huakang Medical Products Factory Present in Europe in other categories	China	–	registered
Apothecaries Sundries Mfg Pvt Ltd	India	–	registered
BANDAGE-EN CORSETINDUSTRIE BASKO B.V.	Netherlands	–	registered
BECKER ORTHOPEDIC APPLIANCE CO. Present in Europe in other categories	United States	–	registered
BMS Great Lakes LLC	United States	–	registered
BRACEUS INDUSTRIES CO., LIMITED	Hong Kong SAR China	–	registered
BSN medical GmbH Present in Europe in other categories	Germany	–	registered
Backpod Limited	New Zealand	–	registered
Bauerfeind AG Present in Europe in other categories	Germany	–	registered
BeoCare Inc.	United States	–	registered
Bishop	United States	–	registered
Blunding S.A.	Chile	–	registered
Border Opportunity Saver Systems, Inc.	United States	–	registered
Brace Align	United States	–	registered
BraceAbility, Inc.	United States	–	registered
CAM THANH TOY COMPANY LIMITED	Vietnam	–	registered
CBR Enterprise Limited	Hong Kong SAR China	–	registered
CMS Sports Inc.	United States	–	registered
COMATRIX TECHNOLOGY VIETNAM COMPANY LIMITED	Vietnam	–	registered
COMFORT PLUS CORPORATION	Taiwan	–	registered
CR UNO Industrial Co. LTD	Taiwan	–	registered
CYBERDYNE, INC. Present in Europe in other categories	Japan	–	registered
Caerus Medical Present in Europe in other categories	United States	–	registered
Calze G.T. Srl Present in Europe in other categories	Italy	–	registered
Capital Sports Corporation (Pvt) Ltd.	Pakistan	–	registered
Changsha Yuhong Trading Co., Ltd	China	–	registered
Changzhou Meiguan Care Products Technology Co.,LTD.	China	–	registered
Chengdu Si Hai Mu Ze Technology Co.,Ltd.	China	–	registered
China Effort Limited	China	–	registered
Cixi Cijia Handicraft Co. Ltd	China	–	registered
Cohesion Health International Co., Ltd	China	–	registered
Comfortland International, LLC	United States	–	registered
Concarey Medical Technology Co., Ltd	China	–	registered
Core Products International, Inc. Present in Europe in other categories	United States	–	registered
DIRECSOURCE LIMITED	Hong Kong SAR China	–	registered
DOCBRACE (CAMBODIA) CO., LTD	Cambodia	–	registered
DONGGUAN LEE-MAT SPORTS TECHNOLOGY CO., LTD	China	–	registered
DONGGUAN RUITAI SPORTS TECHNOLOGY CO., LTD	China	–	registered
DONGGUAN SUPERCARE MEDICAL PRODUCTS CO., LTD Present in Europe in other categories	China	–	registered
DONGGUAN WELL SPORT CO LTD	China	–	registered
DU-HOPE INTERNATIONAL GROUP	China	–	registered
DYNAMIC TECHNO MEDICALS PRIVATE LIMITED	India	–	registered
Daiso USA LLC	United States	–	registered
Dela Incorporated	United States	–	registered
Dong Guan Yunzhishang Health Technology Co.,ltd.	China	–	registered

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