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Digital Pregnancy Tests
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HCG-U35Da
Identity
- Trade Name
- Digital Pregnancy Tests EUDAMED
- Device Name
- Digital Pregnancy Tests EUDAMED
- Model / Reference
- HCG-U35Da EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804817671 EUDAMED
- Basic UDI-DI
- B-06952804817671 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Digital Pregnancy Tests by Assure Tech. (hangzhou) Co., Ltd. — Class IVD devices for self-testing — 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-06952804817671 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 73f6066d-f861-436d-8abc-6a13fea2a566 61 fields · synced Jun 17, 2026