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Sources: EU EUDAMED, US FDA
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252.954
Certificate
MDD Annex II (excluding section 4)·Biosensors Europe SA·National Standards Authority of Ireland (NSAI)·37 Basic UDI-DIs
2116857CE08
Certificate
MDD Annex II (excluding section 4)·Biosensors Europe SA·DEKRA Certification B.V.·57 Basic UDI-DIs
2116857DE08
Certificate
MDD Annex II Section 4·Biosensors Europe SA·DEKRA Certification B.V.·56 Basic UDI-DIs
2116857DE08
Certificate
MDD Annex II Section 4·Biosensors Europe SA·DEKRA Certification B.V.·1 Basic UDI-DI
252.954
Certificate
MDD Annex II (excluding section 4)·Biosensors Europe SA·National Standards Authority of Ireland (NSAI)·1 Basic UDI-DI
2116857CE05
Certificate
MDD Annex II (excluding section 4)·Biosensors Europe SA·DEKRA Certification B.V.·87 Basic UDI-DIs
2116857DE04
Certificate
MDD Annex II Section 4·Biosensors Europe SA·DEKRA Certification B.V.·49 Basic UDI-DIs
2116857CE05
Certificate
MDD Annex II (excluding section 4)·Biosensors Europe SA·DEKRA Certification B.V.·3 Basic UDI-DIs
2116857DE04
Certificate
MDD Annex II Section 4·Biosensors Europe SA·DEKRA Certification B.V.·3 Basic UDI-DIs
2116857DE09
Certificate
MDD Annex II Section 4·Biosensors Europe SA·DEKRA Certification B.V.·38 Basic UDI-DIs
CE 544967
Certificate
MDD Annex II (excluding section 4)·Tristel Solutions Limited·BSI Group The Netherlands B.V.·25 Basic UDI-DIs
HZ 2181688-1
Certificate
MDR QMS·Operating Theatre Medical (Zhijiang) Co., Ltd·TÜV Rheinland LGA Products GmbH
CN23/00005220
Certificate
MDR QMS·Atlas Copco (Wuxi) Compressor Co., Ltd.·SGS Belgium NV
n.0068/QCO-D/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·1 Basic UDI-DI
n.0068/QCO-DM/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·11 Basic UDI-DIs
24M00068CRT01
Certificate
MDR QMS·FEops NV·Kiwa Dare B.V.
BE24/00000171
Certificate
MDR QMS·Qaelum NV·SGS Belgium NV
BE24/00000069
Certificate
MDR QMS·Mondomed NV·SGS Belgium NV
23M00082CRT01
Certificate
MDR QMS·ArtiQ NV·Kiwa Dare B.V.
20M00107CRT01
Certificate
MDR QMS·FLUIDDA NV·Kiwa Dare B.V.