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DAB Substrate Kit
EUDAMEDClass A (EU MDR)
Ref 957D-20Model 957D-X seriesRef 957D-30
Identity
- Trade Name
- DAB Substrate Kit EUDAMED
- Device Name
- DAB Substrate Kit EUDAMED
- Model / Reference
- 957D-X series EUDAMED957D-20 EUDAMED957D-30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683104803 EUDAMED00841683104810 EUDAMED
- Basic UDI-DI
- 008416831957DV3 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
DAB Substrate Kit by Cell Marque Corporation — Class A — 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 | 008416831957DV3 | 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 2f172c13-d823-4d59-ae6a-20752e0138ed 61 fields · synced Jul 9, 2026
- EUDAMED 1ae9f5c9-6b30-4c85-8772-1d18bbd7c6ad 61 fields · synced May 18, 2026