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CMV (DDG9/CCH2) Mouse Monoclonal Antibody

EUDAMED

Class C (EU MDR)

Ref 213M-15Model 213M-1X seriesRef 213M-17

by Cell Marque Corporation

Identity

Trade Name
CMV (DDG9/CCH2) Mouse Monoclonal Antibody EUDAMED
Device Name
CMV (DDG9/CCH2) Mouse Monoclonal Antibody EUDAMED
Model / Reference
213M-1X series EUDAMED
213M-15 EUDAMED
213M-17 EUDAMED

Identifiers

Primary DI / UDI-DI
00841683126874 EUDAMED
00841683126935 EUDAMED
Basic UDI-DI
008416831213M-1B3 EUDAMED
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

CMV (DDG9/CCH2) Mouse Monoclonal Antibody by Cell Marque Corporation — Class C — 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
US-MF-000028332
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED d451c0bd-41ba-49b6-ae57-b09844b015bf 61 fields · synced Jul 31, 2026
  • EUDAMED 842f8efd-9bd6-47ac-8368-4a0e6f263578 61 fields · synced May 19, 2026