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Automated ECLImmunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 0120512Model eCL9000、eCL9600、eCL9900、eCL9900i
Identity
- Trade Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Device Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Model / Reference
- eCL9000、eCL9600、eCL9900、eCL9900i EUDAMED0120512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062365 EUDAMED
- Basic UDI-DI
- 6970341680120503HB EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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 | 6970341680120503HB | 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 7713348c-1279-42b6-8c9b-5004dcde6b28 61 fields · synced Jun 19, 2026