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Pregnancy Test Strips
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 21482Model Strip
Identity
- Trade Name
- PREGNANCY TEST STRIPS EUDAMED
- Device Name
- HCG Pregnancy Tests EUDAMED
- Model / Reference
- Strip EUDAMED21482 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134863 EUDAMED16942468134860 EUDAMED
- Basic UDI-DI
- B-06942468134863 EUDAMEDB-16942468134860 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Pregnancy Test Strips by Core Technology 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-06942468134863 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Core Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023522
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED d45372db-fdb5-4334-b2d2-c2a007d9e673 61 fields · synced Jul 17, 2026
- EUDAMED 855b9637-310e-42fd-845a-a4ae0e16ae16 61 fields · synced May 18, 2026