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β-Human Chorionic Gonadotropin (β-HCG) Test Kit(Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52026018Model 25T/kitRef 52027018Model 50T/Kit
Identity
- Device Name
- β-Human Chorionic Gonadotropin (β-HCG) Test Kit(Immunofluorescence) EUDAMED
- Model / Reference
- 25T/kit EUDAMED52026018 EUDAMED50T/Kit EUDAMED52027018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334808558 EUDAMEDD-FA0019ZD EUDAMED
- Basic UDI-DI
- B-06950334808558 EUDAMEDB-FA0019ZD EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class IVD General 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
β-Human Chorionic Gonadotropin (β-HCG) Test Kit(Immunofluorescence) by Genrui Biotech Inc. — 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-06950334808558 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED c579b0e5-3b3a-4c04-b282-318e30b5c4d8 61 fields · synced Jul 31, 2026
- EUDAMED 84f70486-88ac-4c66-9a83-75c23a634588 61 fields · synced May 17, 2026