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Automated ECLImmunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 012130601Model eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p
Identity
- Trade Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Device Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Model / Reference
- eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p EUDAMED012130601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139070802 EUDAMED
- Basic UDI-DI
- 6970341680120504HD EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 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 ECLImmunoassay 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 | 6970341680120504HD | Class A | 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 (1)
- EUDAMED 7b5ab6a9-5532-4d98-9056-9fbc27945d5a 61 fields · synced Jun 19, 2026