Identity
- Trade Name
- MAGLUMI Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 130299039M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145567972 EUDAMED
- Basic UDI-DI
- 69471455345WC 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 Sample Diluent 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 | 69471455345WC | 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 89900f52-e00c-499d-99ce-6647dcdc069b 61 fields · synced Jul 22, 2026