Non-woven balls
by Shaoxing Yibon Medical Co., Ltd. 5 variants
Ref 2418124, 2418113, 2418111, 2418116Model I
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 | Number6972370762200000M8 | Date18 Dec 2024 | 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- Withdrawn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
- Non-woven swabs/balls/pads
- Model / Reference
- I, 2418124, 2418113, 2418111, 2418116
- Primary DI / UDI-DI
- 06937437814068, 06937437814648, 06937437814037, 06937437814112
- Basic UDI-DI
- 6972370762200000M8
- EMDN Code
- M020299 Non-woven gauzes - other
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000003378
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Shaoxing Yibon 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