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Browiner
EUDAMEDClass IIb (EU MDR)
Ref 0801080019Model MobileSparkler 300A, MobileSparkler 300B, MobileSparkler 300CRef 0801080238Model PerfoX 3000A, PerfoX 3000B-1, PerfoX 3000B-2Ref 0801080052Model MobileCooperRef 0801080049Model MobileGenius A, MobileGenius BRef 0801080261Model PerfoX 5500A, PerfoX 5500BRef 0801080048Ref 0801080355Model CompaX 500A, CompaX 500B, CompaX 500C
Identity
- Trade Name
- Browiner EUDAMED
- Device Name
- Digital Radiography System EUDAMEDDigital Radiography and Radioscopy System EUDAMEDMobile C-arm X-ray System EUDAMED
- Model / Reference
- MobileSparkler 300A, MobileSparkler 300B, MobileSparkler 300C EUDAMED0801080019 EUDAMEDPerfoX 3000A, PerfoX 3000B-1, PerfoX 3000B-2 EUDAMED0801080238 EUDAMEDMobileCooper EUDAMED0801080052 EUDAMEDMobileGenius A, MobileGenius B EUDAMED0801080049 EUDAMEDPerfoX 5500A, PerfoX 5500B EUDAMED0801080261 EUDAMED0801080048 EUDAMEDCompaX 500A, CompaX 500B, CompaX 500C EUDAMED0801080355 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974426220097 EUDAMED06974426220202 EUDAMED06974426220127 EUDAMED06974426220110 EUDAMED06974426220226 EUDAMED06974426220103 EUDAMED06974426220158 EUDAMED
- Basic UDI-DI
- 697442622MX30LU EUDAMED697442622DX51K5 EUDAMED697442622MX20LR EUDAMED697442622MX40LX EUDAMED697442622DX55KD EUDAMED697442622CX100DL EUDAMED
- Direct Marketing DI
- 06974426220097 EUDAMED06974426220202 EUDAMED06974426220127 EUDAMED06974426220110 EUDAMED06974426220226 EUDAMED06974426220103 EUDAMED06974426220158 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDRomania EUDAMEDSpain EUDAMEDGermany 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 (7)
- EUDAMED 692a1b44-4d34-4b27-ac72-bc52e82e260d 61 fields · synced Aug 1, 2026
- EUDAMED 82075db0-132e-4757-88a8-bf6d0c29d5d5 61 fields · synced May 17, 2026
- EUDAMED 38fde7b9-871c-44b2-bb7b-dc99848c9c68 61 fields · synced May 17, 2026
- EUDAMED 14ae42a6-fb6e-4059-939d-cfb29c66434f 61 fields · synced May 18, 2026
- EUDAMED d8182b18-6d4c-4c10-a66a-98d9d05f794a 61 fields · synced Jul 9, 2026
- EUDAMED e2da5ab1-08da-44ce-8b54-2d6dd119c9e3 61 fields · synced Jul 14, 2026
- EUDAMED 17be82f1-e4c4-48f0-b2b0-772576b5ad6c 61 fields · synced Jul 16, 2026