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Cytokeratin 19 Antibody Reagent (Immunohistochemistry)
EUDAMEDClass IVD General (EU MDR)
Ref RMA1A012
Identity
- Trade Name
- Cytokeratin 19 Antibody Reagent (Immunohistochemistry) EUDAMED
- Device Name
- Cytokeratin 19 Antibody Reagent (Immunohistochemistry) EUDAMED
- Model / Reference
- RMA1A012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927210901245 EUDAMED
- Basic UDI-DI
- B-06927210901245 EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Cytokeratin 19 Antibody Reagent (Immunohistochemistry) by Shenzhen Dartmon Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06927210901245 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dartmon Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4aab3b5d-3fba-47b1-b2ef-79a703ed2249 61 fields · synced Oct 9, 2026