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One Step hCG Urine Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref C1103Model strip
Identity
- Device Name
- One Step hCG Urine Test EUDAMED
- Model / Reference
- strip EUDAMEDC1103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970725810373 EUDAMED
- Basic UDI-DI
- B-06970725810373 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany 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 Test by Atlas Link 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-06970725810373 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Atlas Link Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021058
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 4b10f995-0bf0-43d2-badc-0b7f8dbddf5d 61 fields · synced Jul 10, 2026