Adhesive Bandage (Wound Plaster)
by Hyegiir Medical Supply CO LTD
Ref 85104Model 85104, 85325, 85167, 85354, 85356, 85001, 85115, 85105, 85362, 85364, 85366, 75704, 75707, 75708
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 | Number69483487AB001M8 | Date14 Aug 2024 | StatusActive |
Certificates
No notified-body 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- Withdrawn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 (Wound Plaster)
- Model / Reference
- 85104, 85325, 85167, 85354, 85356, 85001, 85115, 85105, 85362, 85364, 85366, 75704, 75707, 75708
- Primary DI / UDI-DI
- 06948348701613
- Basic UDI-DI
- 69483487AB001M8
- EMDN Code
- M03030202 Skin protective bandages
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000043643
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hyegiir Medical Supply 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