Identity
- Trade Name
- MAGLUMI GAD65 (CLIA) EUDAMED
- Device Name
- GAD65 (CLIA) EUDAMED
- Model / Reference
- 130205005M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145501679 EUDAMED
- Basic UDI-DI
- B-06947145501679 EUDAMED
- EMDN Code
- W0102060105 GAD II ANTIBODIES AND OTHER ICA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Maglumi Gad65 (clia) by Shenzhen New Industries Biomedical Engineering 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-06947145501679 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005655
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e866049c-9dad-453a-becc-584a9d890816 61 fields · synced Jul 9, 2026