Identity
- Trade Name
- MAGLUMI Reaction Cup EUDAMED
- Device Name
- Reaction Cup EUDAMED
- Model / Reference
- 130105000101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145512712 EUDAMED
- Basic UDI-DI
- 69471455306W2 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 Cup 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 | 69471455306W2 | 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 6c9a90a3-9949-4a15-ac41-e445ef1962b2 61 fields · synced Oct 6, 2026
- EUDAMED bca3c6df-1b75-4496-a551-c6ae72112775 61 fields · synced Aug 3, 2026