Gauze balls
by Shaoxing Yibon Medical Co., Ltd. 15 variants
Part of a family of 58 devices: see the family page
Ref 1418107Model I
Gauze balls (1418107) is a Class I device made by Shaoxing Yibon Medical Co., Ltd., registered in EUDAMED on 18 Dec 2024 (Basic UDI-DI 6972370761200000LP), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6972370761200000LP 06937437815331 | Date18 Dec 2024 | StatusActive |
Official records
- EUDAMED public site 6972370761200000LP
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- Withdrawn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 swabs/balls/rolls
- Model / reference
- I, 1418107
- Primary DI / UDI-DI
- 06937437815331
- Basic UDI-DI
- 6972370761200000LP
- EMDN code
- M020199 Cotton gauzes - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000003378
- Authorised representative
- Obelis s.a. BE-AR-000000106
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