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LH Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320302702Model 25 Tests/Kit
Identity
- Trade Name
- LH Test (FIA) EUDAMED
- Device Name
- LH Test (FIA) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED0320302702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139071304 EUDAMED06978139075845 EUDAMED
- Basic UDI-DI
- B-06978139071304 EUDAMEDB-06978139075845 EUDAMED
- EMDN Code
- W0102060304 CROSS-LINKED C-TELOPEPTIDES 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
LH Test (FIA) 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-06978139071304 | 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 (2)
- EUDAMED 87b81972-ce42-46c2-903a-dd93c92adb87 61 fields · synced Jul 15, 2026
- EUDAMED d9ba0b3c-d0c1-4dc3-9fa1-938c86ce8dde 61 fields · synced May 19, 2026