Adhesive bandage(non-sterile)
by GAUKE Healthcare Co., Ltd 3 variants
Ref Kon-10x4, Kon-10x8, gauke-10x4Model Non-woven、PE、Elastic fabric、Elastic fabric
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 | Number69514547302V2 | Date2 Oct 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- Withdrawn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
- Adhesive bandage
- Model / Reference
- Non-woven、PE、Elastic fabric、Elastic fabric, Kon-10x4, Kon-10x8, gauke-10x4
- Primary DI / UDI-DI
- 06951454766674, 06951454740001, 06951454724704
- Basic UDI-DI
- 69514547302V2
- EMDN Code
- M03030202 Skin protective bandages
- Device Class
- Class I
- EU market of registration
- AustriaSlovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000013784
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Gauke Healthcare Co., Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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