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IL-6 STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510103Model 100TRef 0320510102Model 2×50TRef 0320510104Model 2×100TRef 0320510101Model 50TModel 50T，2×50T，100T，2×100T
Identity
- Trade Name
- IL-6 STAT (eCLIA) EUDAMED
- Device Name
- IL-6 STAT (eCLIA) EUDAMED
- Model / Reference
- 100T EUDAMED0320510103 EUDAMED2×50T EUDAMED0320510102 EUDAMED2×100T EUDAMED0320510104 EUDAMED50T EUDAMED0320510101 EUDAMED50T，2×50T，100T，2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064031 EUDAMED06975984064024 EUDAMED06975984064048 EUDAMED06975984064017 EUDAMED
- Basic UDI-DI
- B-06975984064031 EUDAMEDB-06975984064024 EUDAMEDB-06975984064048 EUDAMEDB-06975984064017 EUDAMED69703416803205094JW EUDAMED
- EMDN Code
- W01030609 INTERLEUKIN 6 (IL-6) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
New Device
No
EUDAMED
IL-6 STAT (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975984064031 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984064031 | Class IVD General | 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 b04500c7-4058-4e1d-97a9-1f4f2eff1e72 61 fields · synced Aug 1, 2026
- EUDAMED c09c383a-41a0-4caf-a60a-ba7aa1fca741 61 fields · synced May 17, 2026
- EUDAMED 6b41e2b6-c62b-4426-a183-61f2020be3a6 61 fields · synced May 18, 2026
- EUDAMED fc364892-454e-416e-94f5-b7f886d3aa66 61 fields · synced May 18, 2026
- EUDAMED 791b8f3a-1a89-49a8-914e-a9c58963b9c0 61 fields · synced Aug 1, 2026