Swaes
Ref SWA-8ML-SWAP, SWA-1L-TROF
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 | Number087215166502SWALGELR2 | Date27 Mar 2026 | 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- Withdrawn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
- Medyz Swallowing Gel
- Model / Reference
- SWA-8ML-SWAP, SWA-1L-TROF
- Primary DI / UDI-DI
- 08721516650368, 08721516650245
- Basic UDI-DI
- 087215166502SWALGELR2
- Direct Marketing DI
- 0872151665036808721516650245
- EMDN Code
- V9017 Oral administration preparations not included in other classes
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000051388
Other devices from Medyz BV
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