← Back to catalogue
S100 (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509104Model 2×100 TRef 0320509102Model 2×50 T
Identity
- Trade Name
- S100 (eCLIA) EUDAMED
- Device Name
- S100 (eCLIA) EUDAMED
- Model / Reference
- 2×100 T EUDAMED0320509104 EUDAMED2×50 T EUDAMED0320509102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063768 EUDAMED06975984063744 EUDAMED
- Basic UDI-DI
- B-06975984063768 EUDAMEDB-06975984063744 EUDAMED
- EMDN Code
- W0102030399 OTHER ONCOPROTEINS 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
S100 (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-06975984063768 | 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
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 42017f08-65aa-4e47-a54c-79b338b54791 61 fields · synced Jul 28, 2026
- EUDAMED a51257e6-e24b-4322-8832-21345c8ec8ea 61 fields · synced May 18, 2026