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One Step LH Urine Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref C1107Model CassetteRef C1106Model StripRef C1108Model Midstream Stick
Identity
- Device Name
- One Step LH Urine Test EUDAMED
- Model / Reference
- Cassette EUDAMEDC1107 EUDAMEDStrip EUDAMEDC1106 EUDAMEDMidstream Stick EUDAMEDC1108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970725810410 EUDAMED06970725810403 EUDAMED06970725810427 EUDAMED
- Basic UDI-DI
- B-06970725810410 EUDAMEDB-06970725810403 EUDAMEDB-06970725810427 EUDAMED
- EMDN Code
- W0102160304 LH - 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
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step LH 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-06970725810410 | 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 (3)
- EUDAMED 39746270-81f5-4919-8639-21c60083d39b 61 fields · synced Aug 2, 2026
- EUDAMED 10f2cb88-50e7-4e0c-aaeb-e08e2add25ce 61 fields · synced May 17, 2026
- EUDAMED b0874e72-a257-4130-91ca-1ca5975becdb 61 fields · synced May 19, 2026