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One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref /
Identity
- Trade Name
- One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold) EUDAMED
- Device Name
- One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935091671980 EUDAMED
- Basic UDI-DI
- B-06935091671980 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold) by Qingdao Hightop Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in…
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-06935091671980 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016890
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 920bf73a-2de0-4f92-9472-119977c67ed3 61 fields · synced Jul 9, 2026