008 Waye Readers Black / Readers 20
by Disentis AB
Ref WR0008R001-20Model WR0008
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 | Number7350145WR0008ME 07350145359581 | Date17 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- Withdrawn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
- 008 Waye Readers
- Model / Reference
- WR0008, WR0008R001-20
- Primary DI / UDI-DI
- 07350145359581
- Basic UDI-DI
- 7350145WR0008ME
- EMDN Code
- Q0210030101 Ready to wear metal spectacles with organic lenses
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000050466
Other devices from Disentis AB
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