cohesive bandage
by Nanjing Hi-Tech Tape Products Co.，LTD. 4 variants
Ref Class I, rule 1 of MDR Annex VII
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 | Number697452806FBZN02MX 06974528060010 | Date15 Mar 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- Withdrawn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
- cohesive bandage
- Model / Reference
- Class I, rule 1 of MDR Annex VII
- Primary DI / UDI-DI
- 06974528060010
- Basic UDI-DI
- 697452806FBZN02MX
- EMDN Code
- M0303010201, M0303010203
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000002226
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Nanjing Hi-Tech Tape Products Co.，LTD.
See all devices from Nanjing Hi-Tech Tape Products 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