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Emdyca

Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instruments

Neonatology instruments

EMDN code Z120804

58 manufacturers, 448 models including 436 on the market, 22 countries

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Manufacturers registered in Europe (EUDAMED) 58
  • 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.
ManufacturerCountryRegistered modelsClassContact
Ningbo David Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
101 others
 IIa, IIb MDR, 93/42 Website EUDAMED record Report an error
Lumitex FDA EU representative : MDSS GmbH (Germany) United States
95 others
 IIa 93/42 Website EUDAMED record Report an error
Weyer Germany
14 others
 IIa, IIb 93/42 Website info@weyermed.com EUDAMED record Report an error
Draeger FDA EU representative : Drägerwerk AG & Co. KGaA (Germany) Germany, United States
18 others
 IIa, IIb MDR, 93/42 Website EUDAMED@draeger.com EUDAMED record Report an error
Atom Medical FDA EU representative : Emergo Europe B.V. (Netherlands) Japan
12 others
 IIa, IIb 93/42 Website infoEU@atomed.co.jp EUDAMED record Report an error
Being Technology EU representative : phoenix Medtech GmbH (Germany) China
7 others
 IIa, IIb 93/42 EUDAMED record Report an error
Mediprema France
7 others
 IIa, IIb 93/42 qualite@mediprema.com EUDAMED record Report an error
Phoenix Medical Systems EU representative : Obelis s.a. (Belgium) India
6 others
 I, IIa, IIb MDR, 93/42 Website EUDAMED record Report an error
Niceneotech EU representative : Amstermed B.V. (Netherlands) India
5 others
 IIa, IIb MDR, 93/42 Website EUDAMED record Report an error
Datex-Ohmeda FDA EU representative : GE Medical Systems SCS (France) United States
4 others
 I, IIa, IIb MDR eudamed@gehealthcare.com EUDAMED record Report an error
Ginevri Italy
3 others
 IIa, IIb 93/42 Website mail@ginevri.com EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China
3 others
 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Unimed FDA Poland
2 others
 IIb 93/42 Website EUDAMED record Report an error
David Medical Europe, Unipessoal Lda Portugal
1 other
 IIa, IIb MDR info@davideuropa.pt EUDAMED record Report an error
Ertunç Özcan Türkiye
1 other
 IIa, IIb 93/42 Website EUDAMED record Report an error
Novos Türkiye
1 other
 IIa, IIb 93/42 Website EUDAMED record Report an error
Okuman Türkiye
1 other
 IIb 93/42 Website info@okuman.com.tr EUDAMED record Report an error
Bngmed EU representative : Umedwings Netherlands B.V. (Netherlands) China IIa, IIb MDR, 93/42 Website info@bngmed.com EUDAMED record Report an error
JW Pharmaceutical EU representative : Emergo Europe B.V. (Netherlands) South Korea IIa, IIb 93/42 export@jw-holdings.co.kr EUDAMED record Report an error
Neomedlight FDA France IIa 93/42 Website contact@neomedlight.com EUDAMED record Report an error
Medical Technology Transfer Services EU representative : Logic S.r.l. (Italy) Vietnam IIa, IIb MDR Website info@mtts-asia.com EUDAMED record Report an error
Natus FDA Denmark I, IIa MDR Website EUDAMED record Report an error
Tse Czechia IIa, IIb 93/42 Website EUDAMED record Report an error
Bistos FDA EU representative : Obelis s.a. (Belgium) South Korea IIa, IIb 93/42 Website EUDAMED record Report an error
CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands) and 1 other United States IIa MDR, 93/42 RA-CSI@coopersurgical.com EUDAMED record Report an error
Littlesparrowstech FDA EU representative : CEpartner4U (Netherlands) United States I, IIa MDR Website info@littlesparrowstech.com EUDAMED record Report an error
Sanasol Hungary – 98/79 Website info@mail.sanasol.hu EUDAMED record Report an error
Tende Türkiye IIb 93/42 Website info@tende.com.tr EUDAMED record Report an error
Alfamedic Czechia IIa, IIb MDR, 93/42 Website EUDAMED record Report an error
Astekmed Türkiye IIa MDR, 93/42 Website EUDAMED record Report an error
ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States I, IIa MDR Website info@elitechgroup.com EUDAMED record Report an error
Gerium Medical FDA EU representative : AR Experts B.V. (Netherlands) Israel I, IIa MDR EUDAMED record Report an error
Jablotron Czechia IIb 93/42 EUDAMED record Report an error
PRIM FDA Spain I, IIb MDR Website eudamed1@prim.es EUDAMED record Report an error
Zhengzhou Dison Instrument Meter EU representative : Share info GmbH (Germany) China IIa MDR Website info@zzdison.com EUDAMED record Report an error
Asleep EU representative : SOAR & PARTNERS Sp. z o.o. (Poland) South Korea I MDR EUDAMED record Report an error
Bilihome Netherlands IIa MDR Website regulatory@bilihome.org EUDAMED record Report an error
Charder FDA EU representative : Obelis s.a. (Belgium) Taiwan I MDR Website EUDAMED record Report an error
conceptnatal Germany I MDR Website info@conceptnatal.de EUDAMED record Report an error
Concord Neonatal Netherlands I MDR Website EUDAMED record Report an error
Danyang New Hope Medical Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR Sales@dynewhope.com.cn EUDAMED record Report an error
Emsaş A.Ş Türkiye I MDR Website EUDAMED record Report an error
Fima Global Brands EU representative : GLORY-Cosmetic Hungary Kft. (Hungary) United Kingdom (ex Northern Ireland) I MDR Website info@fima-global.com EUDAMED record Report an error
hestomed Germany IIb MDR Website EUDAMED record Report an error
Hisense FDA EU representative : Obelis s.a. (Belgium) Israel IIb 93/42 EUDAMED record Report an error
International Biomedical FDA Switzerland IIb MDR Website EUDAMED record Report an error
Kern & Sohn Germany I MDR EUDAMED record Report an error
LMT Medical Systems FDA Germany IIb MDR Website info@lmt-medicalsystems.com EUDAMED record Report an error
Mbelec FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa 93/42 EUDAMED record Report an error
MedCare Visions Germany IIb MDR Website info@mcv-group.de EUDAMED record Report an error
Proma Medikal Şti Türkiye I MDR Website EUDAMED record Report an error
Sina Hamd Aria EU representative : S.C PERDAC GLOBAL S.R.L (Romania) Iran IIb MDR Website export3@sinabed.com EUDAMED record Report an error
SLE EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I MDR EUDAMED record Report an error
Tongda Medical Equipment (Zibo) EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
TScale Electronics Mfg. (Kunshan) EU representative : JOYSUN GROUP S.L.U (Spain) China I MDR Website EUDAMED record Report an error
Avihealthcare EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market India IIa, IIb MDR sales@avihealthcare.com EUDAMED record Report an error
Fanem EU representative : Obelis s.a. (Belgium) No model still on the market India IIa MDR, 93/42 Website info@fanem.in EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) No model still on the market United States I MDR eudamed@philips.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) 28

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.

ManufacturerCountryBrandsFDA clearance
AirLife Finland Oy Present in Europe in other categories – Multi-Link™ AirLife™ Airlife registered
NEOLIGHT LLC United States Light Module GelMat Skylife Controller CloudCover Plus CloudCover Skylife Lightbed K170585 (2017)
RPI – LAMP LAMP INCAND 12V 50W FLUORESCENT LAMP (WHITE) FLUORESCENT LAMP (BLUE) LAMP (12VDC 100W) - 6 LAMP (52VDC 50W) registered
MEDTRONIC POWERED SURGICAL SOLUTIONS Present in Europe in other categories United States Midas Rex MR8 registered
ADVANCED INSTRUMENTATIONS, INC. United States ADVANCED NEONATAL INCUBATOR ADVANCED INFANT WARMER ADVANCED LED PHOTOTHERAPY LAMP registered
INTERNATIONAL BIOMEDICAL, LTD. Present in Europe in other categories United States Airborne Phototherapy Light K160238 (2016)
Medela AG Present in Europe in other categories Switzerland Bilibed K984589 (1999)
Physician Engineered Products, Inc. United States Ultra Bili Light K110550 (2012)
TARRY MEDICAL PRODUCTS, INC. Present in Europe in other categories United States Tarry Probes K071977 (2008)
AD Supply Group Limited United Kingdom – registered
Amphenol Thermometrics, Inc. United States – registered
Avalon Biomedical (Shenzhen) Limited China – K200031 (2020)
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. Costa Rica – registered
DEROYAL INDUSTRIES, INC. Present in Europe in other categories United States – registered
DHL Supply Chain (Netherlands) B.V. Netherlands – registered
Draeger Medical Sytems, Inc. United States – K172154 (2018)
Draegerwerk AG & CO Kgaa Germany – K162821 (2017)
FISHER & PAYKEL HEALTHCARE NZ LTD New Zealand – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
Gerium Israel – registered
HERBERT WALDMANN GMBH & CO. United States – registered
Katecho, Inc. United States – registered
Minnetronix Medical, Inc. United States – registered
Mom Incubators Limited United Kingdom – K243437 (2025)
Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company United States – K152814 (2016)
Replacement Parts Industries, Inc. United States – K021531 (2002)
TE Connectivity United States – registered
Thera B Medical Products United States – K251308 (2026)

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