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Rollator
EUDAMEDClass I (EU MDR)
Ref BR0003-5Model BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3, BR0003/BR0003-1/BR0003-2/BR0003-3/BR0003-5 BR0005/BR0005-1/BR0005-2/BR0005-3/BR0005-5 BR0006/BR0006-1/BR0006-2/BR0006-3/BR0006-5
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- BR0001/BR0001-1/BR0001-2/BR0001-3, BR0002/BR0002-1/BR0002-2/BR0002-3, BR0003/BR0003-1/BR0003-2/BR0003-3/BR0003-5 BR0005/BR0005-1/BR0005-2/BR0005-3/BR0005-5 BR0006/BR0006-1/BR0006-2/BR0006-3/BR0006-5 EUDAMEDBR0003-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977176610217 EUDAMED
- Basic UDI-DI
- 697717661BR001HC EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Rollator by Bradacare (XiaMen) Health Technology Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697717661BR001HC | Class I | Active |
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Manufacturer
- Manufacturer
- Bradacare (XiaMen) Health Technology Co., LTD
- EUDAMED SRN
- CN-MF-000042118
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0c173905-fd93-4c64-bf51-3d891ff5d797 61 fields · synced Jun 18, 2026