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Automated ECLImmunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 012130501Model eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800pRef 0120514Model eCL9000、eCL9600、eCL9900、eCL9900iRef 012130101Ref 012130202Ref 0120513
Identity
- Trade Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Device Name
- Automated ECLImmunoassay Analyzer EUDAMED
- Model / Reference
- eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p EUDAMED012130501 EUDAMEDeCL9000、eCL9600、eCL9900、eCL9900i EUDAMED0120514 EUDAMED012130101 EUDAMED012130202 EUDAMED0120513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139070796 EUDAMED06975984062419 EUDAMED06978139070758 EUDAMED06978139070765 EUDAMED06975984062402 EUDAMED
- Basic UDI-DI
- 6970341680120504HD EUDAMED6970341680120503HB EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMEDW0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMEDW0201020103 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 | 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 (5)
- EUDAMED 6c1b53f9-1362-4f61-983e-2cb06c2ab318 61 fields · synced Jul 18, 2026
- EUDAMED 475920b8-f308-4ab4-9f0f-bde2e450972b 61 fields · synced May 17, 2026
- EUDAMED f2082957-ebff-4548-8980-949e347eb8e3 61 fields · synced May 17, 2026
- EUDAMED aa4180ba-55cc-4ecf-9662-cc425b5ac3f8 61 fields · synced May 18, 2026
- EUDAMED f05b8306-7091-45b0-94e6-7655b924d9d2 61 fields · synced May 19, 2026