← Back to catalogue
Ep-CAM Antibody Reagent (Immunohistochemistry)
EUDAMEDClass IVD General (EU MDR)
Ref RMA1A068
Identity
- Trade Name
- Ep-CAM Antibody Reagent (Immunohistochemistry) EUDAMED
- Device Name
- Ep-CAM Antibody Reagent (Immunohistochemistry) EUDAMED
- Model / Reference
- RMA1A068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927210905854 EUDAMED06927210905939 EUDAMED
- Basic UDI-DI
- B-06927210905854 EUDAMEDB-06927210905939 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
Ep-CAM 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-06927210905854 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dartmon Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 9cd17619-e9b7-476a-a632-49ec287b7930 61 fields · synced Oct 10, 2026
- EUDAMED d92f4964-0e8a-43cb-95e9-7b64f003b715 61 fields · synced Oct 9, 2026