Gauze balls
by Hubei V-Medical Products Co., Ltd. 10 variants
Ref 015002-ROModel 18x20cm、20x20cm、25x25cm
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 | Number697023378GauzeBallsXE 26942013214464 | Date8 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- Withdrawn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 Balls 纱布球
- Model / Reference
- 18x20cm、20x20cm、25x25cm, 015002-RO
- Primary DI / UDI-DI
- 26942013214464
- Basic UDI-DI
- 697023378GauzeBallsXE
- Direct Marketing DI
- 06942013214460
- EMDN Code
- M0201020102 Cotton gauzes, folded, without x-ray detectable thread, non-sterile
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000011268
- Authorised representative
- RAFFIN MEDICAL FR-AR-000004632
Other devices from Hubei V-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