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Browiner
EUDAMEDClass IIb (EU MDR)
Ref 0801080018Model MobileSparkler 300A, MobileSparkler 300B, MobileSparkler 300C
Identity
- Trade Name
- Browiner EUDAMED
- Device Name
- Digital Radiography System EUDAMED
- Model / Reference
- MobileSparkler 300A, MobileSparkler 300B, MobileSparkler 300C EUDAMED0801080018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974426220080 EUDAMED
- Basic UDI-DI
- 697442622MX30LU EUDAMED
- Direct Marketing DI
- 06974426220080 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Browiner by Shenzhen Browiner Tech Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697442622MX30LU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Browiner Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000007025
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2b0851f0-ea30-41e1-b211-c53178b03c47 61 fields · synced May 23, 2026