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ALD (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320511803Model 2×100TRef 0320511801Model 100TRef 0320511804Model 2×50T
Identity
- Trade Name
- ALD (eCLIA) EUDAMED
- Device Name
- ALD (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320511803 EUDAMED100T EUDAMED0320511801 EUDAMED2×50T EUDAMED0320511804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067087 EUDAMED06975984067063 EUDAMED06975984067131 EUDAMED
- Basic UDI-DI
- B-06975984067087 EUDAMEDB-06975984067063 EUDAMEDB-06975984067131 EUDAMED
- EMDN Code
- W0102060201 ALDOSTERONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ALD (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — 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-06975984067087 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED a6082938-eba2-4941-b6dd-a888115929bc 61 fields · synced Jul 11, 2026
- EUDAMED 80368f1b-3879-4624-8728-6590c75ea36b 61 fields · synced May 17, 2026
- EUDAMED 9b3482fd-7b6c-4a5e-9801-4b0cd96e7136 61 fields · synced May 18, 2026