008 Waye Readers Black / Readers 35
by Disentis AB EUDAMED
Active
Ref WR0008R001-35Model WR0008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7350145WR0008ME | Date17 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 008 Waye Readers
- Model / Reference
- WR0008, WR0008R001-35
- Primary DI / UDI-DI
- 07350145359611
- Basic UDI-DI
- 7350145WR0008ME
- EMDN Code
- Q0210030102 Ready to wear plastic spectacles with organic lenses
- Device Class
- Class I
- 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