Vandl Nonwoven Swab
Ref YL-99004 / YL-99005 / YL-99007Model 5x5cm-4p 5x5cm-8p
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 | Number++G546YL99001UJ +G546VANDL0025A60 | Date13 Apr 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- Withdrawn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 Swab
- Model / Reference
- 5x5cm-4p 5x5cm-8p, YL-99004 / YL-99005 / YL-99007
- Primary DI / UDI-DI
- +G546VANDL0025A60
- Basic UDI-DI
- ++G546YL99001UJ
- EMDN Code
- M0202030102 Non-woven gauze pads, without x-ray detectable thread, non-sterile
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000037509
- Authorised representative
- MB Global Service B.V. NL-AR-000037296
Other devices from Vandl Biotechnology Inc
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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