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Ind One Step Hcg Rapid Pregnancy Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref SFTHCG-M
Identity
- Trade Name
- IND ONE STEP HCG RAPID PREGNANCY TEST EUDAMED
- Device Name
- ONE STEP HCG RAPID PREGNANCY TEST EUDAMED
- Model / Reference
- SFTHCG-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08697962617340 EUDAMED
- Basic UDI-DI
- B-08697962617340 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Ind One Step Hcg Rapid Pregnancy Test by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — 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-08697962617340 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000046897
Sources (1)
- EUDAMED 317d3eea-5014-4a10-8d4f-41f3dd8d48d7 61 fields · synced Oct 5, 2026