Identity
- Trade Name
- free TESTO (eCLIA) EUDAMED
- Device Name
- free TESTO (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320514701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139075128 EUDAMED
- Basic UDI-DI
- B-06978139075128 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
free TESTO (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-06978139075128 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d9435a27-dac5-4209-a9e2-f971e8ab7a14 61 fields · synced Jul 13, 2026