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Primovert

EUDAMED

Class A (EU MDR)

Ref 415510-1101-000Model Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7

by Carl Zeiss Suzhou Co., Ltd.

Identity

Trade Name
Primovert EUDAMED
Device Name
Inverted microscope EUDAMED
Model / Reference
Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7 EUDAMED
415510-1101-000 EUDAMED

Identifiers

Primary DI / UDI-DI
06909262200071 EUDAMED
Basic UDI-DI
6909262CNA002QB EUDAMED
Direct Marketing DI
06909262200071 EUDAMED
EMDN Code
W0202050303 OPTICAL LABORATORY MICROSCOPES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Primovert by Carl Zeiss Suzhou Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000017606
Authorised Representative
Carl Zeiss Microscopy GmbH DE-AR-000024425

Sources (1)

  • EUDAMED 6486bf4f-bd48-442d-967c-6390f4dec58e 61 fields · synced Jun 18, 2026