Identity
- Trade Name
- MAGLUMI Wash Concentrate EUDAMED
- Device Name
- Wash Concentrate EUDAMED
- Model / Reference
- 130299005M EUDAMED130299035M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145512644 EUDAMED06947145557041 EUDAMED
- Basic UDI-DI
- 69471455303VU 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 Wash Concentrate 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 | 69471455303VU | 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 654841f4-7cb4-4245-a581-eb25d656bd44 61 fields · synced Jul 10, 2026
- EUDAMED 9b8e0436-5eb6-44d1-a300-d80c322cbfce 61 fields · synced May 17, 2026