← Back to catalogue
Testosterone (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 697035Model 50TModel 50T 2×50T 100T 2×100T
Identity
- Trade Name
- Testosterone (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Testosterone (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T EUDAMED697035 EUDAMED50T 2×50T 100T 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689476 EUDAMED
- Basic UDI-DI
- B-06970341689476 EUDAMED69703416803205031J6 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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
New Device
No
EUDAMED
Testosterone (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970341689476 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341689476 | 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 (2)
- EUDAMED bcdef724-6976-48e2-a083-e1d5bb163dcd 61 fields · synced Jul 21, 2026
- EUDAMED 619a5e2d-356d-4b74-a9a2-d66dcc2879b1 61 fields · synced May 17, 2026