Back and Waist Support
by Yangzhou Changqingshu Sports Goods Co., Ltd.
Ref 4621, 6127, 6126, 0107Model 3823, 3824, or customize
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 | Number693477654621MP | Date15 Jun 2023 | 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- Withdrawn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
- Back and Waist SupportBack Support
- Model / Reference
- 3823, 3824, or customize, 4621, 6127, 6126, 0107
- Primary DI / UDI-DI
- 06934776546216, 06934776561271, 06934776561264, 06934776501079
- Basic UDI-DI
- 693477654621MP, 693477656127MQ, 693477656126MN, 693477650107L8
- EMDN Code
- P090799, Y090699
- Device Class
- Class I
- EU market of registration
- AustriaGermanyGreece
Manufacturer details
- EUDAMED SRN
- CN-MF-000019129
- 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