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Permanent Red Chromogen Kit
EUDAMEDClass A (EU MDR)
Ref 960D-20Model 960D-X seriesRef 960D-10
Identity
- Trade Name
- Permanent Red Chromogen Kit EUDAMED
- Device Name
- Permanent Red Chromogen Kit EUDAMED
- Model / Reference
- 960D-X series EUDAMED960D-20 EUDAMED960D-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683101949 EUDAMED00841683101895 EUDAMED
- Basic UDI-DI
- 008416831960DUK EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS 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
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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Permanent Red Chromogen Kit by Cell Marque Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 008416831960DUK | Class A | 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 3c16cfce-bff4-4854-9bbb-2344d9bc4393 61 fields · synced Jul 11, 2026
- EUDAMED 7792d861-581b-47cd-ac72-4332d3e3576c 61 fields · synced May 19, 2026