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Rollator
EUDAMEDClass I (EU MDR)
Ref C1315Model C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etc
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etc EUDAMEDC1315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975831922095 EUDAMED
- Basic UDI-DI
- 697583192ROLLATOR0015H EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Raise Medical Industries Inc. — 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 | 697583192ROLLATOR0015H | Class I | Active |
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Manufacturer
- Manufacturer
- Raise Medical Industries Inc.
- EUDAMED SRN
- CN-MF-000029869
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f38f7e5a-4b4c-45c5-9ea3-fa90034099fc 61 fields · synced Jun 19, 2026