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Chorionic Gonadotropin (hCG) ELISA
EUDAMEDClass IVD General (EU MDR)
Ref CAN-hCG-4120Model 96 Tests
Identity
- Device Name
- Chorionic Gonadotropin (hCG) ELISA EUDAMED
- Model / Reference
- 96 Tests EUDAMEDCAN-hCG-4120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B261CANHCG4120QH EUDAMED
- Basic UDI-DI
- B-++B261CANHCG4120QH EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Chorionic Gonadotropin (hCG) ELISA by Diagnostics Biochem Canada Inc — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-++B261CANHCG4120QH | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc.
- EUDAMED SRN
- CA-MF-000032449
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 3f61b217-1eb4-4a11-830f-1ca6d8bf6bf6 61 fields · synced Jun 18, 2026