Foam underwrap
by Wuxi Wemade Healthcare Products Co., Ltd 14 variants
Ref 3613Model prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size
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 | Number69387992FoamunderwrapEL 06938799236130 | Date17 Jan 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- Withdrawn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
- Foam underwrap
- Model / Reference
- prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, or customized size, 3613
- Primary DI / UDI-DI
- 06938799236130
- Basic UDI-DI
- 69387992FoamunderwrapEL
- EMDN Code
- M04010202 Polyurethane fixing dressings
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000009786
- 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