Rails
by shenzhenshi shenkehengjian yiliaokeji youxian gongsi 4 variants
Ref RL01-CModel RL01-A、RL01-B、RL01-C、RL01-D、RL01-E、RL01-F、RL01-G、RL01-H、RL01-I、RL01-J、RL01-K、RL01-L、RL01-M、RL01-N、RL01-P, 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 | Number698053708RL001GW 06980537088020 | Date25 Sep 2026 | 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- Withdrawn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
- Rails
- Model / Reference
- RL01-A、RL01-B、RL01-C、RL01-D、RL01-E、RL01-F、RL01-G、RL01-H、RL01-I、RL01-J、RL01-K、RL01-L、RL01-M、RL01-N、RL01-P, etc., RL01-C
- Primary DI / UDI-DI
- 06980537088020
- Basic UDI-DI
- 698053708RL001GW
- EMDN Code
- Y181803 Handrails
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000058886
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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