Identity
- Trade Name
- MAGLUMI Starter 1+2 EUDAMED
- Device Name
- Starter 1+2 EUDAMED
- Model / Reference
- 130299004M EUDAMED130299027M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145512675 EUDAMED06947145512682 EUDAMED
- Basic UDI-DI
- 69471455302VS EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
MAGLUMI Starter 1+2 by Shenzhen New Industries Biomedical Engineering 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 | 69471455302VS | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005655
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 53a8f15c-4ef1-45cf-86ee-9a4b05edaca2 61 fields · synced Jul 10, 2026
- EUDAMED e8663c68-ddd9-4c32-ac6c-9c0f85bc1558 61 fields · synced May 18, 2026