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IgE (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320511602Model 2×50TRef 0320511604Model 2×100TRef 0320511601Model 50T
Identity
- Trade Name
- IgE (eCLIA) EUDAMED
- Device Name
- IgE (eCLIA) EUDAMED
- Model / Reference
- 2×50T EUDAMED0320511602 EUDAMED2×100T EUDAMED0320511604 EUDAMED50T EUDAMED0320511601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067445 EUDAMED06975984067438 EUDAMED06975984067421 EUDAMED
- Basic UDI-DI
- B-06975984067445 EUDAMEDB-06975984067438 EUDAMEDB-06975984067421 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
IgE (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975984067445 | 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 (3)
- EUDAMED 3be492cc-abd7-4385-85a0-24727cd54f9c 61 fields · synced Jul 31, 2026
- EUDAMED 921fe3b2-64fa-4a54-af4e-060b5ed5f6fe 61 fields · synced May 17, 2026
- EUDAMED ba5be6d5-0c4b-4b42-ab88-e0fd228bb939 61 fields · synced May 19, 2026