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Maglumi X8
EUDAMEDClass A (EU MDR)
Ref 010101008801Model Fully-auto chemiluminescence immunoassay analyzer
Identity
- Trade Name
- MAGLUMI X8 EUDAMED
- Device Name
- MAGLUMI X8 EUDAMED
- Model / Reference
- Fully-auto chemiluminescence immunoassay analyzer EUDAMED010101008801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947145513467 EUDAMED
- Basic UDI-DI
- 69471455X8GF EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) 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
Yes
EUDAMED
New Device
No
EUDAMED
Maglumi X8 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 | 69471455X8GF | 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 fc037a95-e0f9-41fd-87ae-6055847f8001 61 fields · synced Jun 18, 2026