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Early Pregnancy (hCG) Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref R04-120
Identity
- Device Name
- Early Pregnancy (hCG) Test EUDAMED
- Model / Reference
- R04-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941571800153 EUDAMED
- Basic UDI-DI
- B-06941571800153 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Early Pregnancy (hCG) Test by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. — Class IVD devices for self-testing — 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-06941571800153 | Class IVD devices for self-testing | 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 d4954c32-ab3a-4b85-a178-42ff4f325468 61 fields · synced Jun 18, 2026