MEDWELL Gauze Ball
by Medwell Medical Products Co., Ltd. 18 variants
Ref E31203Model 002M
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 | Number697055784002MCT 06970557842627 | 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- Withdrawn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
- Gauze Ball
- Model / Reference
- 002M, E31203
- Primary DI / UDI-DI
- 06970557842627
- Basic UDI-DI
- 697055784002MCT
- EMDN Code
- M0201020102 Cotton gauzes, folded, 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