Sterile Gauze Swabs
by Medwell Medical Products Co., Ltd. 26 variants
Ref 286545Model B002, B001
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697055784B002EQ 06970557844096 | Date5 Jun 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Sterile Gauze SwabsFcare STERILE GAUZE SWABS
- Device Name
- Sterile Gauze Swab without X-Ray
- Model / Reference
- B002, 286545, B001
- Primary DI / UDI-DI
- 06970557844096
- Basic UDI-DI
- 697055784B002EQ, 697055784B001EN
- EMDN Code
- M0201020101 Cotton gauzes, folded, without x-ray detectable thread, sterile
- Device Class
- Class I
- EU market of registration
- Greece
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 (12)
- 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