Gauze Roll
by Lianyungang baishun medical treatment articles co., ltd 2 variants
Ref 1829Model Cotton Yarn:40*40,32*32,21*21,32*21,16*16,With or without X-ray detectable thread (or tape) Mesh: 11thr,12thr,13thr,15thr,17thr,18thr,20thr,22thr,24a thr,24b thr,24c thr,21c thr,24thr,27.5thr etc
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 | Number697033651gr001RV 06970336511829 | Date18 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- Withdrawn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
- Gauze Roll
- Model / Reference
- Cotton Yarn:40*40, 32*32, 21*21, 32*21, 16*16, With or without X-ray detectable thread (or tape) Mesh: 11thr, 12thr, 13thr, 15thr, 17thr, 18thr, 20thr, 22thr, 24a thr, 24b thr, 24c thr, 21c thr, 24thr, 27.5thr etc, 1829
- Primary DI / UDI-DI
- 06970336511829
- Basic UDI-DI
- 697033651gr001RV
- EMDN Code
- M020199 Cotton gauzes - other
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000010197
- 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