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Sources: EU EUDAMED, US FDA
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2195-MED-2113202
Certificate
MDD Annex II Section 4·Omnimate Enterprise Co., Ltd.·Szutest Uygunluk Değerlendirme A.Ş.·3 Basic UDI-DIs
CE596713
Certificate
MDD Annex II Section 4·Heraeus Medical Components LLC·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE 623392
Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·63 Basic UDI-DIs
CE 677889
Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·13 Basic UDI-DIs
CE 677886
Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·10 Basic UDI-DIs
CE 623391
Certificate
MDD Annex II Section 4·Dongguan Kewei Medical Instrument Co., Ltd.·BSI Group The Netherlands B.V.·49 Basic UDI-DIs
M.2021.106.14504-1
Certificate
MDD Annex II Section 4·Tianjin Zhengtian Medical Instrument Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·87 Basic UDI-DIs
2107788CE06
Certificate
MDD Annex II Section 4·ASAHI INTECC CO., LTD.·DEKRA Certification B.V.·2 Basic UDI-DIs
CN19/41114
Certificate
MDD Annex II Section 4·Beijing KellyMed Co., Ltd.·SGS Belgium NV·15 Basic UDI-DIs
M.2020.106.13582-1
Certificate
MDD Annex II Section 4·Tianjin Zhengtian Medical Instrument Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·212 Basic UDI-DIs
MY/191811030190
Certificate
MDD Annex II Section 4·Nulatex Sdn. Bhd.·SGS Belgium NV·1 Basic UDI-DI
C-01-1183-760-21
Certificate
MDD Annex II Section 4·Pharmia Oy·Eurofins Electric & Electronics Finland Oy·4 Basic UDI-DIs
Directive 93/42/EEC Annex II section 4
Certificate
MDD Annex II Section 4·Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi·HTCert (Health Technology Certification Ltd)·1 Basic UDI-DI
THTR-02-L14
Certificate
MDD Annex II Section 4·Willingsford NL·Eurofins Electric & Electronics Finland Oy·4 Basic UDI-DIs
1434-MDD-340-2020
Certificate
MDD Annex II Section 4·VUP Medical, a.s.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
0068/QCO-DM/406-2021
Certificate
MDD Annex II Section 4·Kaushik Orthopaedic Private Limited·MTIC InterCert S.r.l.·8 Basic UDI-DIs
M.2021.106.14504-1
Certificate
MDD Annex II Section 4·Tianjin Zhengtian Medical Instrument Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·2 Basic UDI-DIs
CE 686786
Certificate
MDD Annex II Section 4·Butterfly Network, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI
10000360569-PA-NA-USA
Certificate
MDD Annex II Section 4·Vycor Medical Inc.·DNV Product Assurance AS·25 Basic UDI-DIs
544291 MRA
Certificate
MDD Annex II Section 4·MicroPort NeuroTech (Shanghai) Co.,Ltd.·DQS Medizinprodukte GmbH·2 Basic UDI-DIs