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MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref MCR-01Ref MCRLFA-01
Identity
- Trade Name
- MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography) EUDAMED
- Device Name
- MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography) EUDAMED
- Model / Reference
- MCR-01 EUDAMEDMCRLFA-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970489560729 EUDAMED06970514081342 EUDAMED
- Basic UDI-DI
- B-06970489560729 EUDAMEDB-06970514081342 EUDAMED
- EMDN Code
- W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography) by Genobio Pharmaceutical 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-06970489560729 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 4ca6c435-782f-42f0-8097-3f162b193a4a 61 fields · synced Jul 9, 2026
- EUDAMED 26173e83-bdfb-4b04-847b-390920691bde 61 fields · synced Jul 9, 2026