Instruments for functional explorations and therapeutic interventionsGeneral medicine instruments

General medicine diagnosis and monitoring instruments

EMDN code Z120401

86 manufacturers, 323 models including 269 on the market, 19 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 86

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
Heine FDA	Germany	DELTA 20 T + CO.PL.W.SCALE DELTA 20 T + CONTACT PLATE2 refs DELTA 20 T SET/4 NT DELTA 20 T SET/4 USB+TR. DELTA 20T DELTA 20T small Contact plate3 refs 20 others DELTA 20T/KIT 1 DELTA 20T/KIT 2 DELTA 307 refs DELTA 30 PRO Bundle DELTA 30 UV DELTA 30 UV PROFESSIONAL DELTA 30 UV ULTIMATE DELTA X DELTA X CPG2 refs DELTA X DERMATOSKOP DELTA X PROFESSIONAL K-131.28.307 DELTA X ULTIMATE DELTAone STANDARD EDITION2 refs diSTANCE EN200-1 SINGLE/DELTA 20 T/KIT HEINE IC1 SET/12 Pro3 refs iC1 mini3000 LED MINI3000 LED DERM.+CONT+HA MINI3000 DERM.+CONT.PL.+HANDLE2 refs mini3000 small Contact plates3 refs	I MDR	Website info@heine.com EUDAMED record Report an error
InBody FDA EU representative : InBody Europe B.V. (Netherlands)	South Korea	BWA ON BWA2.0 BWA2.0S H20/H20B InBody H20B InBody S10 11 others InBody120 InBody260S InBody270 InBody270S InBody280 InBody370S InBody380 InBody770 InBody770S InBody970 InBody970S	IIa MDR	Website EUDAMED record Report an error
Dexcom FDA EU representative : MDSS GmbH (Germany)	United States	Dexcom Clarity3 refs Dexcom Flex CGM System3 refs Dexcom ONE Continuous Glucose Monitoring System STK-DO-013/ Dexcom ONE Receiver Kit (mg/dL)93/42 Dexcom ONE Continuous Glucose Monitoring System STK-DO-109/ Dexcom ONE Receiver Kit (mmol/L)93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-002/ Dexcom ONE Starter Kit - Greece/Romania mg/dL93/42 8 others Dexcom ONE Continuous Glucose Monitoring System STP-DO-003/ Dexcom ONE Starter Kit - Belgium/France mg/dL93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-005/ Dexcom ONE Starter Kit - Spain mg/dL93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-101/ Dexcom ONE Starter Kit - Estonia/Latvia/Lithuania mmol/L93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-102/ mmol/L, Dexcom ONE Starter Kit, Bulgaria93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-109/ Dexcom One Starter Kit - Croatia mmol/L93/42 Dexcom ONE Continuous Glucose Monitoring System STS-DO-001/ Dexcom ONE Sensor 1-pack93/42 Dexcom ONE Continuous Glucose Monitoring System STS-DO-003/ Dexcom ONE Sensor 3-pack93/42 Dexcom ONE Continuous Glucose Monitoring System STT-DO-001/ Dexcom ONE Transmitter93/42	I, IIb MDR, 93/42	Website EUDAMED record Report an error
Dreisam (Beijing) Medical Technology EU representative : Firsteck Bio Srl. (Italy)	China	Dreisam D1/L1/S1/D1 Pro/L1 Pro/S1 Pro Dreisam D2 Dreisam D2 Pro Dreisam D3 Dreisam D3 Pro 8 others Dreisam L2 Dreisam L2 Pro Dreisam L3 Dreisam L3 Pro Dreisam S2 Dreisam S2 Pro Dreisam S3 Dreisam S3 Pro	IIb MDR	EUDAMED record Report an error
Iboolo FDA EU representative : Kingsmead Service B.V. (Netherlands)	China	DE-200 DE-215 DE-300 DE-3100 Pro DE-315 8 others DE-400 DE-4100 DE-4100 Pro DE-415 DE-500 DE-5100 DE-6100 Dermatoscope DE-3100	I MDR	EUDAMED record Report an error
Eaglenos FDA EU representative : MedPath GmbH (Germany)	China	Continuous Glucose Monitoring System D107G Continuous Glucose Monitoring System D107W Continuous Glucose Monitoring System D110G Continuous Glucose Monitoring System D110W Continuous Glucose Monitoring System D114G 7 others Continuous Glucose Monitoring System D114W Continuous Glucose Monitoring System D115B Continuous Glucose Monitoring System D115G Continuous Glucose Monitoring System D115L Continuous Glucose Monitoring System D115N Continuous Glucose Monitoring System D115U Continuous Glucose Monitoring System D115W	IIb MDR	EUDAMED record Report an error
Hiskymedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	FH600093/42 FH800093/42 FH9000,FH8000,FH6000 FT10093/42 FT900093/42 5 others Mini56093/42 Mini900,Mini800,Mini560,FT200,FT100 Plus500093/42 Plus9000,Plus5000,Plus1000 Pro9000,Pro3000,Pro1000,FT9000,FT1000	IIa MDR, 93/42	ra@hiskymedical.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	FreeStyle Libre 2 Flash Glucose Monitoring System (Reader Kit)3 refs FreeStyle Libre 2 Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 2 Plus Flash Glucose Monitoring System (Sensor Kit) / FreeStyle Libre Select Continuous Glucose Monitoring Sensor3 refs FreeStyle Libre 3 app3 refs FreeStyle Libre 3 Continuous Glucose Monitoring System (Reader Kit)3 refs FreeStyle Libre 3 Continuous Glucose Monitoring System (Sensor Kit) / FreeStyle Libre 3 Plus Continuous Glucose Monitoring System (Sensor Kit) / Instinct sensor / Instinct Go sensor3 refs 4 others FreeStyle Libre Pro iQ Continuous Glucose Monitoring System2 refs FreeStyle LibreLink app3 refs Libre3 refs LibreView	IIa, IIb MDR	EUDAMED record Report an error
Firefly Global FDA EU representative : MDSS GmbH (Germany)	United States	DE300 DE308 DE330T DE334T DE337T 4 others DE350 DE370 DE605 DE608	I MDR	Website sales@fireflyglobal.com EUDAMED record Report an error
Sonomed FDA	Poland	Głowica ultradźwiękowa CW493/42 Głowica ultradźwiękowa CW593/42 Głowica ultradźwiękowa PW293/42 Głowica ultradźwiękowa SPW16 bagnetowa93/42 Głowica ultradźwiękowa SPW16 cewnik93/42 2 others Głowica ultradźwiękowa SPW16 zgięta SPW16 zagięta93/42 MD4-CW8 Kieszonkowy detektor przepływu93/42	IIa 93/42	Website EUDAMED record Report an error
Weldoninstrument FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Pakistan	WS-511-006R: Non-Sterile, Reusable, Hartmann Tuning Fork C 12893/42 WS-511-007R: Non-Sterile, Reusable, Hartmann Tuning Fork C1 25693/42 WS-511-008R: Non-Sterile, Reusable, Hartmann Tuning Fork C2 51293/42 WS-511-009R: Non-Sterile, Reusable, Hartmann Tuning Fork C3 102493/42 WS-511-010R: Non-Sterile, Reusable, Hartmann Tuning Fork C4 204893/42 2 others WS-511-011R: Non-Sterile, Reusable, Hartmann Tuning Fork C5 409693/42 WS-512-012R: Non-Sterile, Reusable, Set Of Tuning Forks Hartmann C 128, C1 256, C2 512, C3 1024, C4 204893/42	I 93/42	Website EUDAMED record Report an error
Compumedics Germany FDA	Germany	Doppler BoxX3 refs EZ Dop K1 EZ-Dop Series3 refs Multi-Dop T2 refs Multi-Dop X digital2 refs93/42 Multi-Dop X digital with CO2 measuring module93/42 1 other Multi-Dop X digital with Color Doppler imaging module93/42	IIa MDR, 93/42	Website info@dwl.de EUDAMED record Report an error
Cook Vandergrift FDA EU representative : COOK MEDICAL EUROPE LIMITED (Ireland)	United States	BLOOD FLOW MONITOR DP-M35093/42 Charger for Doppler Blood Flow Monitor COOK-SWARTZ DOPPLER FLOW PROBE - LONG CUFF93/42 COOK-SWARTZ DOPPLER FLOW PROBE - STANDARD CUFF93/42 COOK-SWARTZ DOPPLER FLOW PROBE EXTENSION CABLE93/42 1 other Doppler Blood Flow Monitor Channel/Cable Verifier	I, IIa, IIb MDR, 93/42	Website EUDAMED record Report an error
Neko Health FDA	Sweden	BDEM-01 Derma-1 Derma-2 NekoLens Spectrum-1 1 other Spectrum-2	I MDR	Website hello@nekohealth.com EUDAMED record Report an error
Roche FDA	Germany	Accu-Chek98/79 Accu-Chek Aviva98/79 Accu-Chek Guide98/79 Accu-Chek Insight98/79 Accu-Chek Instant2 refs98/79 1 other Accu-Chek Mobile2 refs98/79	– 98/79	Website EUDAMED record Report an error
Infinovo EU representative : Llins Service & Consulting GmbH (Germany)	China	Glunovo D393/42 Glunovo i393/42 Glunovo p393/42 Glunovo SI3-WL-0393/42 Glunovo SP3-WL-0393/42	IIa 93/42	Info@infinovo.com EUDAMED record Report an error
Respironics FDA EU representative : Respironics Deutschland GmbH & Co.KG (Germany)	United States	AW CT Angelini 152PO17433 Pkg Scorer93/42 AW CT Immusoft MT2018-18 Pkg Scorer93/42 AW CT Janssen 42847922MDD1005 Scorer93/42 AW CT Ultragenyx UX701-CL001 Pkg Scorer93/42 Actiware Clinical Trial Software, English - 693/42 (no longer marketed) 46 others Actiware Software CD - 693/42 (no longer marketed) Actiware Software Pkg., Addl License BOM93/42 (no longer marketed) Actiware Software Web Download - 693/42 (no longer marketed) Actiwatch Spectrum Device Actiwatch 2 and Actiwatch Spectrum93/42 (no longer marketed) Actiwatch Spectrum Plus-Recertified93/42 (no longer marketed) Actiwatch Spectrum Plus-Rental93/42 (no longer marketed) Actiwatch Spectrum PRO93/42 (no longer marketed) Actiwatch Spectrum PRO-Recertified93/42 (no longer marketed) Actiwatch Spectrum PRO-Rental93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Scorer93/42 (no longer marketed) AW CT Sanifit SNFCT2020-07 Site93/42 (no longer marketed) AW CT Bayer 20887 Scorer93/42 (no longer marketed) AW CT Bayer 20887 Site93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Scorer93/42 (no longer marketed) AW CT Insmed INS 415 Pkg Site93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Scorer93/42 (no longer marketed) AW CT Insmed INS 416 Pkg Site93/42 (no longer marketed) AW CT Janssen 42756493BLC3001 Pkg Scorer93/42 (no longer marketed) AW CT Janssen 42847922MDD1005 Site93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Scorer93/42 (no longer marketed) AW CT Janssen 42847922MDD3001 Site93/42 (no longer marketed) AW CT Janssen CNTO1275CRD3007 Pkg Scorer93/42 (no longer marketed) AW CT Janssen NOPRODBIP0001 Pkg Scorer93/42 (no longer marketed) AW CT Kiniksa KPL-716-C001 Pkg Scorer93/42 (no longer marketed) AW CT Kiniksa KPL-OBS001 Pkg Scorer93/42 (no longer marketed) AW CT Koneksa Pkg LPS16677 Site93/42 (no longer marketed) AW CT MT-8554-E06 Pkg Scorer93/42 (no longer marketed) AW CT Novartis CAIN457FUS06 Pkg Scorer93/42 (no longer marketed) AW CT Ovid OV101-17-001 Pkg Scorer93/42 (no longer marketed) AW CT Ovid OV101-17-002 Pkg Scorer93/42 (no longer marketed) AW CT Regeneron R3500-AD-1798 Pkg Scorer93/42 (no longer marketed) AW CT Roche BP29937 Pkg Scorer93/42 (no longer marketed) AW CT TAK-994-1503 Scorer93/42 (no longer marketed) AW CT TAK-994-1503 Site93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Scorer93/42 (no longer marketed) AW CT Takeda TAK-925-2001 Pkg Site93/42 (no longer marketed) AW CT Takeda TAK-925-2002 Pkg Scorer93/42 (no longer marketed) AW CT Takeda TAK-994-1501 Pkg Site93/42 (no longer marketed) AW CT Ultragenyx UX701-CL001 Pkg Site93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Scorer93/42 (no longer marketed) AW CT Vanda VP-VEC-162-3502 Pkg Site93/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Scorer-693/42 (no longer marketed) CT Sanofi LPS15497 Software Pkg Site93/42 (no longer marketed) CT XyloCor XC001-1001 SW Pkg Scorer93/42 (no longer marketed) Disposable Invasive Circuits93/42 (no longer marketed) Novartis Software PkgScorer93/42 (no longer marketed)	IIa 93/42	eudamed@philips.com EUDAMED record Report an error
IDCP	Netherlands	Dino-Lite CapillaryScope3 refs Dino-Lite DermaScope3 refs Dino-Lite PodoScope Dino-Lite TrichoScope3 refs	I MDR	Website EUDAMED record Report an error
Sinocare FDA EU representative : Obelis s.a. (Belgium)	China	GlucoMen® iCan i3, o33 refs GlucoMen® iCan view Glucose Data Reader iCGM-V3 Sinocare iCan i3, o3 Sinocare iCan i6, H6, i7, H72 refs	IIb MDR	RA@sinocare.com EUDAMED record Report an error
Idmed FDA	France	AlgiScan ALG-Cable AlgiScan ALG-MU AlgiScan ALG-System2 refs	IIa MDR	info@idmed.fr EUDAMED record Report an error
Italeco	Italy	Video Capillaroscope3 refs Video Dermatoscope3 refs VIDEODERMATOSCOPIO PER USO IN DERMATOLOGIA (FUNZIONE MEDICALE) E PER USO IN CAMPO ESTETICO (FUNZIONE NON -MEDICALE).	I MDR	Website info@italeco.com EUDAMED record Report an error
MicroTech Medical (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain)	China	DiaExpert GX-01F, GX-02F3 refs LinX GX-01S；GX-02S3 refs WELLION G7-S01；G7-S01A；G7-S01B2 refs	IIb MDR	Website EUDAMED record Report an error
PSI Plus FDA EU representative : SMGeurope OÜ (Estonia)	South Korea	Camera, still, surgical 3D Meta-Vu Camera, still, surgical Mark-Vu Camera, still, surgical Mark-Vu W	I MDR	EUDAMED record Report an error
Sisensing EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	SIBIONICS GS1 Continuous Glucose Monitoring System SIBIONICS GS1 ECO Continuous Glucose Monitoring System GS1-P2 SIBIONICS GS3 Continuous Glucose Monitoring System2 refs	IIb MDR	Website support@sibionics.com EUDAMED record Report an error
Transonic FDA EU representative : Transonic Europe BV (Netherlands)	United States	H4FX Clamp-on Tubing Flowsensors HD033 refs Standard FlowXL Meter with AdvancedFlow Software2 refs Tubing Flowsensors3 refs	IIa MDR	Website regulatory@transonic.com EUDAMED record Report an error
Zhejiang POCTech EU representative : Prolinx GmbH (Germany)	China	CT-312 CT-312C Pic CGM WEARABLE SENSOR CT-3023 refs	IIb MDR	service@poctechcorp.com EUDAMED record Report an error
Bionime FDA EU representative : Emergo Europe B.V. (Netherlands)	Taiwan	Inreda HS3122 refs Inreda HS5103 refs	IIb MDR	EUDAMED record Report an error
Canfieldsci FDA EU representative : CANFIELD SCIENTIFIC SRL (Italy)	United States	D2 Dermatoscope 51400 VEOS 51550	I MDR	EUDAMED record Report an error
Casio EU representative : MedNet EC-REP GmbH (Germany)	Japan	DZ-D100 Dermatology Camera DZ-S50 Dermatology Scope	I MDR	info_prrc1-yam@casio.co.jp EUDAMED record Report an error
CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands)	United States	DP-M350-CHG1 DP-MCV01	I MDR	RA-CSI@coopersurgical.com EUDAMED record Report an error
DermLite FDA EU representative : E C REP LIMITED (Ireland)	United States	A-UNI DermLite Devices including DL5P and Skeen SK23 refs DERMLITE DL5-IC25	I MDR	Website EUDAMED record Report an error
em-tec	Germany	SonoTTTM aQuila I SonoTT™ Clamp-On SL3 refs	I MDR	Website EUDAMED record Report an error
Fotofinder FDA	Germany	FotoFinder leviacam FotoFinder medicam 1000	I MDR	info@fotofinder.de EUDAMED record Report an error
Hash Sign EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)	Pakistan	Dermatoscopes / Dermoscopes Packed In Hard Case – Black Head HS-04-032 Dermatoscopes / Dermoscopes Packed In Hard Case – Grey Head HS-04-031	I MDR	EUDAMED record Report an error
Humedics	Germany	LiMAx FLIP 4.093/42 LiMAx Messgerät FLIP 4.0	IIb MDR, 93/42	Website info@humedics.de EUDAMED record Report an error
i-SENS FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	ALLYcgm Continuous Glucose Monitoring System3 refs CareSens Air 2 Continuous Glucose Monitoring System	IIb MDR	Website regulatory@i-sens.com EUDAMED record Report an error
Illuco FDA EU representative : AeMi World e.K (Germany)	South Korea	IDS-9100 ILLUCO IDS-11002 refs	I MDR	Website info@illuco.co.kr EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	MMT-5113JWY MMT-84002 refs	IIa MDR	EUDAMED record Report an error
Shenzhen Cofoe Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	CMCC01 CMSC013 refs	IIb MDR	EUDAMED record Report an error
Medtrum EU representative : Medtrum B.V. (Netherlands)	China	TouchCare Glucose Sensor MD-JY-0062 refs93/42 (no longer marketed) Glucose Sensor MD302693/42 (no longer marketed) Glucose Sensor MD365893/42 (no longer marketed) Gluose Sensor JY-01693/42 (no longer marketed) 2 others Transmitter MD102693/42 (no longer marketed) Transmitter MD115893/42 (no longer marketed)	IIa, IIb MDR, 93/42	info@medtrum.com EUDAMED record Report an error
Melatech	Denmark	Dermkit na DERMKIT1 (no longer marketed)	I MDR	Website contact@melatech.io EUDAMED record Report an error
Adamosrl	Italy	ATON 100 ATON series3 refs	I MDR	Website info@adamosrl.com EUDAMED record Report an error
Alta Lab	Italy	MEDICALSCOPE FB-16-50-20	I MDR	info@altalab.it EUDAMED record Report an error
Angionica	Poland	AngioExpert	IIa MDR	Website EUDAMED record Report an error
Aprikos Medical	Norway	Aprikos Medical3 refs	I MDR	Website info@aprikosmedical.com EUDAMED record Report an error
Arjo FDA	Sweden	DOPPLEX DMX3 refs	IIa MDR	Website info@arjo.com EUDAMED record Report an error
Aspensurgical FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	Symmetry®3 refs	I MDR	Website customerservice@aspensurgical.com EUDAMED record Report an error
Auas Instruments EU representative : ANTEX MEDI SOLUTION (Germany)	Pakistan	AUAS Intsruments Tunning Forks (Non-Sterile and Reusable)3 refs	I MDR	EUDAMED record Report an error
Augmedical	Poland	Dermatoscopes3 refs	I MDR	Website info@augmedical.pl EUDAMED record Report an error
Biotekna FDA	Italy	HEG	IIa MDR	EUDAMED record Report an error
Chin Kou Medical Instrument FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	Deluxe Adjustment Tuning Fork (128 CPS) CK-9003 refs	I MDR	Website info@spiritmedical.com.tw EUDAMED record Report an error
Community Dermatology EU representative : CS Life Sciences Europe Ltd (Ireland)	United Kingdom (ex Northern Ireland)	Dyplens	I MDR	Website support@mapmymole.com EUDAMED record Report an error
Corsano FDA	Netherlands	CardioWatch 287-2 CardioWatch 287-13 refs	IIa MDR	info@corsano.com EUDAMED record Report an error
DeepX Health FDA EU representative : Medical Device Management Ltd (Ireland)	United Kingdom (ex Northern Ireland)	OTD Dermatoscope BAL 2000	I MDR	Website EUDAMED record Report an error
Doccheck	Germany	Scaut	I MDR	EUDAMED record Report an error
Ds Medica	Italy	VideoCap 3.0 D1	I MDR	info@dsmedica.info EUDAMED record Report an error
Ekal EU representative : CMC Medical Devices & Drugs SL (Spain)	Pakistan	Ekal Surgical Works Dermatoscopes (Non-Sterile and Reusable)2 refs	I MDR	Website EUDAMED record Report an error
eKare FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	eKare inSight RM IRM	I MDR	Website info@ekareinc.com EUDAMED record Report an error
EyeSense	Germany	FiberSense CGM System FS-DT-0101	IIb MDR	info@eyesense.com EUDAMED record Report an error
Gavimedica	Italy	VIDEODERMATOSCOPIO DIGITALE DERMALVIEW	I MDR	Website EUDAMED record Report an error
Hippo Medical Pte EU representative : PureCE B.V. (Netherlands)	Singapore	Hippo H1	IIb MDR	EUDAMED record Report an error
Igluco Tech	Spain	GLUCUBE ES0201	IIa MDR	Website regulatory@glucube.com EUDAMED record Report an error
Impeto Medical FDA	France	SUDOSCAN SUDO293/42	IIa 93/42	Website regulatory@withings.com EUDAMED record Report an error
Inspectis	Sweden	Inspectis Digital Capillaroscope IN-001	I MDR	Website info@inspect-is.com EUDAMED record Report an error
Kirchner & Wilhelm FDA	Germany	EUROLIGHT D30 Dermatoscope, 2,5 V in bag3 refs	I MDR	Website info@kawemed.de EUDAMED record Report an error
LD Technology FDA EU representative : Neomedica Iberia (Spain)	United States	LD Technology A001	IIa MDR	Website EUDAMED record Report an error
Luxamed FDA	Germany	LuxaScope Dermatoskop LED 2.5 V, black, Polarisation, WITH Scale3 refs	I MDR	Website info@luxamed.de EUDAMED record Report an error
Magnosco	Germany	Magnos®	I MDR	Website info@magnosco.com EUDAMED record Report an error
Mde Kft	Hungary	Neurometer high accuracy measuring device93/42	IIa 93/42	Website info@mdegmbh.eu EUDAMED record Report an error
Med-Storm Innovation FDA	Norway	PAM REF 1002	IIa MDR	Website support@med-storm.com EUDAMED record Report an error
Medical Devices EU representative : Obelis s.a. (Belgium)	Pakistan	Contact Plate Plain, OMNI 30003 refs	I MDR	Website EUDAMED record Report an error
Medimaging Integrated Solution FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	MiiS Horus Scope DDC series2 refs	I MDR	ra@miis.com.tw EUDAMED record Report an error
Medizintechnik FDA	Germany	AS Medizintechnik3 refs	I MDR	Website info@AS-Medizintechnik.de EUDAMED record Report an error
Mercury Produzione	Italy	DS-1	I MDR	Website EUDAMED record Report an error
Microport FDA EU representative : MicroPort Medical B.V. (Netherlands)	China	ArgusClarityTM Insight-10093/42	IIb 93/42	EUDAMED record Report an error
Pixience	France	C-CUBE EDITION DERMATOLOGY	I MDR	Website contact@pixience.com EUDAMED record Report an error
PPRS	France	Somno-Art Device	IIa MDR	Website contact@pprs-research.com EUDAMED record Report an error
Scibase FDA	Sweden	Nevisense3 refs	IIa MDR	Website info@scibase.com EUDAMED record Report an error
SG Manufacturers FDA EU representative : International Business Compendious of Sweden (Sweden)	Pakistan	DERMATOSCOPE3 refs	I MDR	Website sales@sgminstruments.com EUDAMED record Report an error
Sunstar FDA EU representative : Sunstar France (France)	Switzerland	BUTLER PALPETER 99P800093/42	I 93/42	Website regulatory@ch.sunstar.com EUDAMED record Report an error
Surtex Instruments FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United Kingdom (ex Northern Ireland)	Apollo Standard Dermatoscope 50554459DIAGNOSTI040108FX	I MDR	Website info@surtex-instruments.co.uk EUDAMED record Report an error
Syai EU representative : Luxus Lebenswelt GmbH (Germany)	Singapore	Syai X1, M83 refs	IIb MDR	EUDAMED record Report an error
Synapsor EU representative : Luxus Lebenswelt GmbH (Germany)	China	Syai X12 refs	IIb MDR	RA_Group@synapsor.com EUDAMED record Report an error
Teljane EU representative : TRANSMED GLOBAL CONSULTING, S.L. (Spain)	China	CleverCheck Instara-G1 TX-14, TX-213 refs	IIb MDR	EUDAMED record Report an error
Zepf Medical Instruments	Germany	WARTENBERG Nadelrad 18 cm Sensibilitätsmesser	I MDR	Website info@zepf-medical-instruments.de EUDAMED record Report an error
Zumax Medical FDA EU representative : MedNet EC-REP GmbH (Germany)	China	DS200	I MDR	sales@zumaxmedical.com 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) 281

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
PARKS MEDICAL ELECTRONICS, INC.	United States	8.2MHz SKNY PEN PROBE 10' 9.3MHZ PENCIL PROBE 841/842 8.2MHZ MICROVASCULAR PROBE 8.5MHZ ADULT FLAT PROBE 3.9MHz Pencil Probe 7 Foot ODU connector 9.1MHZ PENCIL PROBE 7'	registered
Intl. Medical, Inc.	United States	BV Medical KaWe	registered
American Diagnostic Corp. Present in Europe in other categories	United States	ADC® Adlite™ Plus Pro's Combo™ Metalite™ II Metalite™ Adlite™ II	registered
RASHMAN CORPORATION	United States	Tuning Fork Tuning Fork with Weights Penlight	registered
TAYLOR PRECISION PRODUCTS, INC.	–	Taylor Homedics EatSmart Bowflex Brookstone Metro	registered
Conair Corp.	United States	CONAIR CONAIR CORPORATION	registered
Tanita Corp. of America Present in Europe in other categories	United States	TANITA/Ironman Body Composition Monitor TANITA Body Composition Analyzer TANITA Body Composition Monitor TANITA Body Fat Monitor TANITA/FitScan Body Composition Monitor Body Composition Analyzer	K100183 (2011)
Koven Technology, Inc. Present in Europe in other categories	United States	Pencil probe Adaptor HD-307 BT5M05S8C T5M05S8C LRP-08	K153762 (2016)
QUALITY ASPIRATORS, INC. Present in Europe in other categories	United States	Q-Optics M-OR RADC25 RADFIL1 M-CZ RADFILM6	registered
INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories	United States	Integra® Miltex® Integra® Integra® Jarit®	registered
RZ-Medizintechnik GmbH Present in Europe in other categories	Germany	RZ Medizintechnik GmbH	registered
Rudolf Riester GmbH & Co. KG	Germany	Pack of 6 pcs. ri-pen® ri-pen® red ri-pen® violett, ri-pen® silver ri-pen® green e-xam LED 2.5 V, black	registered
FENTEX medical GmbH Present in Europe in other categories	Germany	FENTEX	registered
Greater Goods	–	Weight Gurus Balance Greater Goods	registered
TYTO CARE LTD Present in Europe in other categories	Israel	TytoHome Tyto Device TytoPro TytoCare	registered
HNM STAINLESS, LLC.	–	HNM MEDICAL	registered
LONG ISLAND TECH	–	Daymark Headlight System Fiji Headband BayPort 6-Bay Charger Dover Headlight Optic Bristol Holster Bristol Headlight Optic	registered
BR Surgical, LLC	–	BR Surgical, LLC	registered
Bear-Ent, LLC	United States	BEAR	registered
CorVascular	–	VasoGuard	registered
MetaOptima Technology Inc	Canada	MoleScope II	registered
Avalign Technologies, Inc.	United States	Millennium Avalign	registered
DEN-MAT HOLDINGS, LLC	United States	PeriOptix Flashlite®	registered
LIFESPAN BRANDS LLC	–	Detecto WeighRite	registered
NOVO SURGICAL, INC.	–	Novo Surgical Novo Surgical Inc Novo Surgical Inc.	registered
SONTEC INSTRUMENTS, INC.	United States	SONTEC TUNING FORK Tuning Fork	registered
AMBLER SURGICAL CORP.	–	Ambler Surgical	registered
Jarden Consumer Solutions	–	Health-O-Meter Sunbeam	registered
Surgitel	–	SurgiTel	registered
Shenzhen Unique Scales Co., Ltd	China	Analyzer,Body composition	registered
Dr Vampa S.R.L.	–	Dr. Vampa	registered
Ecleris	United States	PORTALED PICO LED	registered
Medical Illumination International Inc.	United States	IsoLED Flex I LED Exam Light IsoLED Flex III LED Exam Light	registered
Wuxi Emsrun Technology Co., Ltd.	–	EMSRUN Lightning X Products,Inc	registered
Beaver-Visitec International, Inc.	United States	Blu-Spot Doctors Penlight Nurse-Mate® Max-Lite	registered
Bodystat , Ltd. Present in Europe in other categories	Brazil	Bodystat	K082254 (2011)
ImpediMed Limited Present in Europe in other categories	Australia	BioImp Body Composition Analysis Software SFB7 Imp SFB7	K052319 (2006)
MDF Instruments Medifriend Inc. Present in Europe in other categories	China	MDF®	registered
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.	–	eufy belter efuy	registered
TELEFLEX INCORPORATED Present in Europe in other categories	United States	PILLING	registered
VISIOMED GROUP	France	BEWELL CONNECT MyScale BEWELL CONNECT MyBabyScale	registered
Clearspec LLC	–	ClearSpec	registered
GSOURCE LLC	United States	gSource	registered
HTC AMERICA, INC.	–	HTC	registered
Omron Healthcare, Inc. Present in Europe in other categories	United States	Full Body Sensor Body Composition Monitor and Scale Omron Body Composition Monitor and Scale with Bluetooth	K062043 (2006)
ANDESFIT LIMITED	–	Andnesfit Health	registered
Aesculap, Inc. Present in Europe in other categories	United States	AESCULAP	registered
BETTER BASICS, INC.	–	Body fat scale	registered
Bionix, LLC Present in Europe in other categories	United States	Rechargeable Light Source Light Source	registered
Bistos Co., Ltd. Present in Europe in other categories	United States	–	registered
CEEK WOMEN'S HEALTH	United States	Nella VuLight	registered
COMMONPATH LLC	–	Ozeri	registered
Conmed Corporation Present in Europe in other categories	United States	FLX-LITE	registered
Dynarex Corporation	United States	Reusable Penlight Disposable Penlight	registered
MEDSOURCE INTERNATIONAL LLC	–	MedSource Disposable Pen Light	registered
NATIONAL DISTRIBUTION & CONTRACTING, INC.	–	PRO ADVANTAGE	registered
SELVAS Healthcare, Inc. Present in Europe in other categories	South Korea	ACCUNIQ	registered
Spiggle & Theis Medizintechnik GmbH Present in Europe in other categories	–	Barany noise apparatus Olive tip	registered
The Trustee for KAISER FAMILY TRUST	–	INKA	registered
ADAM ELEMENTS INTERNATIONAL CO., LTD.	–	Transtek	registered
AIOBIO CO.,LTD	South Korea	AIOBIO	registered
BEURER NORTH AMERICA, L.P.	–	Beurer	registered
BOUND TREE MEDICAL, LLC	–	Curaplex	registered
Bausch & Lomb, Inc. Present in Europe in other categories	United States	Bausch + Lomb	registered
CEREBROTECH MEDICAL SYSTEMS INC	–	Cerebrotech Fluids Monitor	registered
Concordance Healthcare Solutions LLC	–	HCS	registered
ESCALI CORP	–	Escali	registered
Gimmi GmbH Present in Europe in other categories	Netherlands	Gimmi	registered
Happersberger Otopront GmbH Present in Europe in other categories	Greece	OTOPRONT	registered
Karl Storz GmbH & Co. KG Present in Europe in other categories	Germany	n.a.	registered
MCKESSON MEDICAL-SURGICAL INC.	–	McKesson	registered
N S SURGICAL COMPANY	–	Tuning Fork Metal Alloy C128	registered
Ningbo Tealmed Emergency Products Co., Ltd.	–	Tealmed	registered
Philips Medical Systems Hsg	–	–	registered
QARDIO, INC.	United States	QardioBase	registered
SEDATELEC Present in Europe in other categories	United States	Premio 40 - Light	registered
SUGIH INSTRUMENDO ABADI, PT	Indonesia	ABN Deluxe Penlight	registered
SURGIX MEDICAL LLC	United States	GEN2	registered
Shenzhen NearbyExpress Technology Development Company Limited	–	TAOTRONICS Wireless Body Composition Smart Scale	registered
Shenzhen Pump Medical System Co., Ltd. Present in Europe in other categories	China	IGuerburn	registered
Star Elite Inc	Canada	Sunbeam	registered
Surgical Design, Inc.	United States	Surgical Design	registered
Tz Medical, Inc. Present in Europe in other categories	United States	TruBrite Adhesive Retractor Light	registered
US VASCULAR LLC	United States	VascuLab	K131860 (2013)
Utah Medical Products, Inc. Present in Europe in other categories	United States	OptiSpec	registered
VALUE PROVIDERS LLC	–	Eocene	registered
VIVE HEALTH LLC Present in Europe in other categories	United States	VIVE	registered
WALGREEN CO.	–	Well at Walgreens	registered
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	–	CVS Health	registered
ACCOMPANY SURGICAL	Pakistan	–	registered
ADC Ningbo Co., Ltd.	China	–	registered
AID UNITED INTERNATIONAL CO., LIMITED Present in Europe in other categories	China	–	registered
ARI Medical Technology Co., Ltd. Present in Europe in other categories	China	–	registered
Acheron Instruments (Pvt.) Ltd. Present in Europe in other categories	Pakistan	–	registered
Admetec Solution LTD	Israel	–	registered
Andon Health Co, Ltd. Present in Europe in other categories	China	–	K120896 (2012)
Armatech International	Pakistan	–	registered
Avilign Medical	Pakistan	–	registered
B. Ali Impex	Pakistan	–	registered
BAILEY INSTRUMENTS LTD	United Kingdom	–	registered

The 100 most active manufacturers are shown, out of 281.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories