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NG-TEST® HCG Whole Blood
EUDAMEDClass IVD General (EU MDR)
Ref VIB-HCG-W21-001
by NG Biotech
Identity
- Trade Name
- NG-TEST® HCG Whole Blood EUDAMED
- Device Name
- NG-TEST® HCG Whole Blood EUDAMED
- Model / Reference
- VIB-HCG-W21-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701077400157 EUDAMED
- Basic UDI-DI
- B-03701077400157 EUDAMED
- EMDN Code
- W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NG-TEST® HCG Whole Blood by Ng Biotech — 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-03701077400157 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NG Biotech
- EUDAMED SRN
- FR-MF-000016216
Sources (1)
- EUDAMED 559af7ac-ff6a-4e3c-8eac-bf4f2ec55ade 61 fields · synced Jun 19, 2026