Identity
- Trade Name
- MAGLUMI Reaction Module EUDAMED
- Device Name
- Reaction Module EUDAMED
- Model / Reference
- 630003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16947145512658 EUDAMED
- Basic UDI-DI
- 69471455301VQ EUDAMED
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES 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
No
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 Reaction Module 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 | 69471455301VQ | 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 (1)
- EUDAMED 1836a9ce-9a76-46ab-be0e-5504e86a4576 61 fields · synced Jun 20, 2026