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LGC Clinical Diagnostics, Inc.

Manufacturer
🇺🇸 United States·84 Basic UDI-DIs·84 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Vycor Medical Inc.

Manufacturer
🇺🇸 United States·26 Basic UDI-DIs·26 Devices·4 Importers·DNV Product Assurance AS and DNV Product Assurance AS

Uromedica, Incorporated

Manufacturer
🇺🇸 United States·17 Basic UDI-DIs·17 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Respiratory Technology Corporation

Manufacturer
🇺🇸 United States·13 Basic UDI-DIs·13 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Cedars-Sinai Medical Center

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

NorthEast Monitoring, Inc.

Manufacturer
🇺🇸 United States·6 Basic UDI-DIs·13 Devices·INTERTEK SEMKO AB

LGC Clinical Diagnostics, Inc.

Manufacturer
🇺🇸 United States·133 Basic UDI-DIs·133 Devices·DEKRA Certification B.V.

Eyenuk, Inc.

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

G1 045789 0018

Certificate
MDD Annex II Section 4·Uromedica, Incorporated·TÜV SÜD Product Service GmbH·14 Basic UDI-DIs

10000360569-PA-NA-USA

Certificate
MDD Annex II Section 4·Vycor Medical Inc.·DNV Product Assurance AS·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

1434-MDD-228/2020

Certificate
MDD Annex II Section 4·Respiratory Technology Corporation·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·13 Basic UDI-DIs

Q5 045789 0019

Certificate
MDD Annex II (excluding section 4)·Uromedica, Incorporated·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

G1038760001

Certificate
MDD Annex II (excluding section 4)·Cedars-Sinai Medical Center·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

41314934-05

Certificate
MDD Annex II (excluding section 4)·NorthEast Monitoring, Inc.·INTERTEK SEMKO AB·3 Basic UDI-DIs

41302127-00

Certificate
MDD Annex II (excluding section 4)·Eyenuk, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI

575325

Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·BSI Group The Netherlands B.V.·6 Basic UDI-DIs

CE 575325

Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·BSI Group The Netherlands B.V.·12 Basic UDI-DIs

3822623

Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·DEKRA Certification B.V.·133 Basic UDI-DIs

CE 572685

Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·BSI Group The Netherlands B.V.·13 Basic UDI-DIs