Plaster of Paris Bandage
Ref 5cm x 2.7mModel 5cm x 2.7m, 7.5cm x 2.7m, 10cm x 2.7m, 15cm x 2.7m, 20cm x 2.7m 5cm x 3.6m, 7.5cm x 3.6m, 10cm x 3.6m, 15cm x 3.6m, 20cm x 3.6m 5cm x 3m, 7.5cm x 3m, 10cm x 3m, 15cm x 3m, 20cm x 3m 6cm x 3m, 8cm x 3m, 12cm x 3m, 14cm x 3m 10cm x 4m, 12cm x 4m, 15cm x 4m
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 | Number697586538PPB001VC 06974286370208 | Date6 Mar 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- Withdrawn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
- Plaster of Paris Bandage
- Model / Reference
- 5cm x 2.7m, 7.5cm x 2.7m, 10cm x 2.7m, 15cm x 2.7m, 20cm x 2.7m 5cm x 3.6m, 7.5cm x 3.6m, 10cm x 3.6m, 15cm x 3.6m, 20cm x 3.6m 5cm x 3m, 7.5cm x 3m, 10cm x 3m, 15cm x 3m, 20cm x 3m 6cm x 3m, 8cm x 3m, 12cm x 3m, 14cm x 3m 10cm x 4m, 12cm x 4m, 15cm x 4m
- Primary DI / UDI-DI
- 06974286370208
- Basic UDI-DI
- 697586538PPB001VC
- EMDN Code
- M03050201 Natural cast bandages and splints
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046056
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Forlong Medical 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