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Rollator
EUDAMEDClass I (EU MDR)
Ref C1336Model C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etcRef C1301
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etc EUDAMEDC1336 EUDAMEDC1301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975831922279 EUDAMED06975831922002 EUDAMED
- Basic UDI-DI
- 697583192ROLLATOR0015H EUDAMED
- Direct Marketing DI
- 06975831922002 EUDAMED
- EMDN Code
- Y120612 WALKING TROLLEYS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDAustria 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 (2)
- EUDAMED 86bed6cd-942d-40b0-868f-fe1b3ee9c471 61 fields · synced Jul 30, 2026
- EUDAMED bdcae958-e49e-47da-b0f4-c6c417f0d8b1 61 fields · synced May 16, 2026