Flexible Waterproof Bandages
by Hubei Decen Biotechnology Co., Ltd 14 variants
Ref polyurethane/2 in x 4 in (51mm x 102mm)Model polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm,polyethylene/19mm x72mm,polyethylene/25mm x 76mm
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 | Number697316144FWB01F3 06973161440074 | Date4 Apr 2025 | 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- Withdrawn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
- Flexible Waterproof Bandages
- Model / Reference
- polyurethane/16mm x 57mm, polyurethane/19mm x 57mm, polyurethane/19mm x72mm, polyurethane/25mm x 76mm, polyurethane/38mm x 38mm, polyurethane/51mm x 76mm, polyurethane/51mm x 102mm, polyethylene/19mm x72mm, polyethylene/25mm x 76mm, polyurethane/2 in x 4 in (51mm x 102mm)
- Primary DI / UDI-DI
- 06973161440074
- Basic UDI-DI
- 697316144FWB01F3
- EMDN Code
- M03030299 Protection systems - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000003013
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Decen Biotechnology 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