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SV40 (MRQ-4) Mouse Monoclonal Antibody
EUDAMEDClass C (EU MDR)
Ref 351M-16Model 351M-1X seriesRef 351M-14
Identity
- Trade Name
- SV40 (MRQ-4) Mouse Monoclonal Antibody EUDAMED
- Device Name
- SV40 (MRQ-4) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 351M-1X series EUDAMED351M-16 EUDAMED351M-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683138020 EUDAMED00841683121466 EUDAMED
- Basic UDI-DI
- 008416831351M-1CE 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
SV40 (MRQ-4) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008416831351M-1CE | Class C | Active |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6c395e42-23c9-4f25-b576-13fe3ce3c495 61 fields · synced Sep 17, 2026
- EUDAMED 05ba9caf-6180-4376-90c3-dd1aa8a6ca35 61 fields · synced May 18, 2026