MEDWELL Cutting Gauze
by Medwell Medical Products Co., Ltd. 7 variants
Ref S22100, S30100, S21100, S31100, S55100, S25100, S23100, S24100, S32100, S54100, S33100Model 001I, 002I, 003I
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 | Number697055784001ICG | Date26 May 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- Withdrawn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
- Cutting Gauze
- Model / Reference
- 001I, S22100, 002I, S30100, S21100, 003I, S31100, S55100, S25100, S23100, S24100, S32100, S54100, S33100
- Primary DI / UDI-DI
- 06970557842962, 06970557842894, 06970557842979, 06970557842795, 06970557842870, 06970557842733, 06970557842917, 06970557842948, 06970557842931, 06970557842863, 06970557842757, 06970557842856
- Basic UDI-DI
- 697055784001ICG, 697055784002ICK, 697055784003ICN
- EMDN Code
- M0201010102 Cotton gauzes, cut, without x-ray detectable thread, non-sterile
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000020397
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Medwell Medical Products 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