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hCG Pregnancy Urine Test, Sensitivity 5 mIU
EUDAMEDClass IVD General (EU MDR)
Ref R04-512
Identity
- Device Name
- hCG Pregnancy Urine Test, Sensitivity 5 mIU EUDAMED
- Model / Reference
- R04-512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571804700 EUDAMED
- Basic UDI-DI
- B-06941571804700 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
hCG Pregnancy Urine Test, Sensitivity 5 mIU by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06941571804700 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020607
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 57864f5e-2cf8-4972-8958-a10db26c4b15 61 fields · synced Oct 6, 2026