Rollator
by Raise Medical Industries Inc. 3 variants
Ref C1301Model C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697583192ROLLATOR0015H 06975831922002 | Date24 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Rollator
- Model / Reference
- C1301、C1302、C1305、C1306、C1308、C1311、C1312、C1313、C1314、C1315、C1316、C1317、C1318、C1319、C1321, etc, C1301
- Primary DI / UDI-DI
- 06975831922002
- Basic UDI-DI
- 697583192ROLLATOR0015H
- Direct Marketing DI
- 06975831922002
- EMDN Code
- Y120612 Walking trolleys
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000029869
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Raise Medical Industries Inc.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No