Identity
- Trade Name
- Immunochromogenic Reagent EUDAMED
- Device Name
- Immunochromogenic Reagent EUDAMED
- Model / Reference
- DMRD5149 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927210912876 EUDAMED
- Basic UDI-DI
- B-06927210912876 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS 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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Immunochromogenic Reagent by Shenzhen Dartmon Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06927210912876 | 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 3c743395-5c26-4204-bc34-5f46b2ea2e3d 61 fields · synced Oct 7, 2026