← Back to catalogue
Automated ECL Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref NAModel eCL8000,eCL8000i,eCL8000p,eCL8000x, Robot_R1
Identity
- Trade Name
- Automated ECL Immunoassay Analyzer EUDAMED
- Device Name
- Automated ECL Immunoassay Analyzer EUDAMED
- Model / Reference
- eCL8000,eCL8000i,eCL8000p,eCL8000x, Robot_R1 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062839 EUDAMED
- Basic UDI-DI
- 6970341680120502H9 EUDAMED
- Direct Marketing DI
- 06975984062839 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated ECL Immunoassay Analyzer by Shenzhen Lifotronic Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970341680120502H9 | Class A | 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 8b326f39-00a2-4169-868d-e75066960a11 61 fields · synced Jun 18, 2026
- EUDAMED 8b326f39-00a2-4169-868d-e75066960a11-1 61 fields · synced Jun 10, 2026