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Emdyca

Instruments for functional explorations and therapeutic interventionsObstetrics and gynaecology instrumentsNeonatology instruments

Paediatric phototherapy equipment

EMDN code Z12080401

32 manufacturers, 179 models including 176 on the market, 15 countries

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Manufacturers registered in Europe (EUDAMED) 32
  • 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
Lumitex FDA EU representative : MDSS GmbH (Germany) United States
95 others
 IIa 93/42 Website EUDAMED record Report an error
Ningbo David Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
14 others
 IIa MDR, 93/42 Website EUDAMED record Report an error
Neomedlight FDA France IIa 93/42 Website contact@neomedlight.com EUDAMED record Report an error
Atom Medical FDA EU representative : Emergo Europe B.V. (Netherlands) Japan IIa 93/42 Website infoEU@atomed.co.jp EUDAMED record Report an error
Mediprema France IIa 93/42 qualite@mediprema.com EUDAMED record Report an error
Natus FDA Denmark I, IIa MDR Website EUDAMED record Report an error
Phoenix Medical Systems EU representative : Obelis s.a. (Belgium) India IIa, IIb 93/42 Website EUDAMED record Report an error
Being Technology EU representative : phoenix Medtech GmbH (Germany) China IIa 93/42 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
Novos Türkiye IIa 93/42 Website EUDAMED record Report an error
Astekmed Türkiye IIa MDR, 93/42 Website EUDAMED record Report an error
Bngmed EU representative : Umedwings Netherlands B.V. (Netherlands) China IIa 93/42 Website info@bngmed.com EUDAMED record Report an error
Datex-Ohmeda FDA EU representative : GE Medical Systems SCS (France) United States IIa MDR eudamed@gehealthcare.com EUDAMED record Report an error
Medical Technology Transfer Services EU representative : Logic S.r.l. (Italy) Vietnam IIa MDR Website info@mtts-asia.com EUDAMED record Report an error
Niceneotech EU representative : Amstermed B.V. (Netherlands) India IIa 93/42 Website EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China IIa MDR 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
Alfamedic Czechia IIa 93/42 Website EUDAMED record Report an error
Bilihome Netherlands IIa MDR Website regulatory@bilihome.org EUDAMED record Report an error
Bistos FDA EU representative : Obelis s.a. (Belgium) South Korea IIa 93/42 Website EUDAMED record Report an error
conceptnatal Germany I MDR Website info@conceptnatal.de EUDAMED record Report an error
David Medical Europe, Unipessoal Lda Portugal IIa MDR info@davideuropa.pt EUDAMED record Report an error
Draeger FDA EU representative : Drägerwerk AG & Co. KGaA (Germany) United States IIa 93/42 Website EUDAMED record Report an error
Ertunç Özcan Türkiye IIa 93/42 Website EUDAMED record Report an error
Gerium Medical FDA EU representative : AR Experts B.V. (Netherlands) Israel IIa MDR EUDAMED record Report an error
Ginevri Italy IIa 93/42 Website mail@ginevri.com EUDAMED record Report an error
JW Pharmaceutical EU representative : Emergo Europe B.V. (Netherlands) South Korea IIa 93/42 export@jw-holdings.co.kr EUDAMED record Report an error
Tende Türkiye IIb 93/42 Website info@tende.com.tr EUDAMED record Report an error
Tse Czechia IIa 93/42 Website EUDAMED record Report an error
Weyer Germany IIa 93/42 Website info@weyermed.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
Avihealthcare EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market India IIa MDR sales@avihealthcare.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) 16

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
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
ADVANCED INSTRUMENTATIONS, INC. United States 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)
Amphenol Thermometrics, Inc. United States – registered
Avalon Biomedical (Shenzhen) Limited China – K200031 (2020)
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
Replacement Parts Industries, Inc. United States – K021531 (2002)
Thera B Medical Products United States – K251308 (2026)

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