Rollator
by Foshan Oscar Medical Instrument Co., Ltd EUDAMED
Active
Ref TRA38-RED, TRA38-BLACKModel TRA01,TRA02,TRA02C,TRA03,TRA04,TRA08,TRA11,TRA14,TRA18,TRA21,TRA32M,TRA34,TRA22,TRA25,TRB01,TRB04,TRB06,TRA01M,TRA33,TRA36,TRA38,TRA38M,TRA40,TRA41,TRA42,TRA43,TRA44,TRA45,TRA46,TRA46M,TRA46F,TRA47,TRA48,TRA49,TRA50,TRA51,TRA52,TRA53,TRA54,TRA55, etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697424257Rollator8P | Date3 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Rollator
- Model / Reference
- TRA01, TRA02, TRA02C, TRA03, TRA04, TRA08, TRA11, TRA14, TRA18, TRA21, TRA32M, TRA34, TRA22, TRA25, TRB01, TRB04, TRB06, TRA01M, TRA33, TRA36, TRA38, TRA38M, TRA40, TRA41, TRA42, TRA43, TRA44, TRA45, TRA46, TRA46M, TRA46F, TRA47, TRA48, TRA49, TRA50, TRA51, TRA52, TRA53, TRA54, TRA55, etc., TRA38-RED, TRA38-BLACK
- Primary DI / UDI-DI
- 06974242570284, 06974242570277
- Basic UDI-DI
- 697424257Rollator8P
- EMDN Code
- Y120609 Walking frames with chair, 4 wheels
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000007958
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Oscar Medical Instrument Co., Ltd
See all devices from Foshan Oscar Medical Instrument Co., Ltd →
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