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Silver Cross Test Di Gravidanza
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 11371Model MidstreamRef 11370
Identity
- Trade Name
- SILVER CROSS TEST DI GRAVIDANZA EUDAMED
- Device Name
- HCG Pregnancy Tests EUDAMED
- Model / Reference
- Midstream EUDAMED11371 EUDAMED11370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134825 EUDAMED06942468134832 EUDAMED
- Basic UDI-DI
- B-06942468134825 EUDAMEDB-06942468134832 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Italy 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
Silver Cross Test Di Gravidanza 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-06942468134825 | 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 f6670f6f-2b36-48f5-8ac3-1a0e3725eeec 61 fields · synced Jul 29, 2026
- EUDAMED 0bc7622e-d83a-41a6-95c0-f0fad2c521e2 61 fields · synced May 18, 2026