Topaz XL HD 22
by Freedom Scientific BLV Group, LLC EUDAMED
Active
Ref 900653-007-MDModel Topaz XL HD 22
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number850018342TOPXLHDTA | Date24 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Topaz XL HD 22
- Model / Reference
- Topaz XL HD 22, 900653-007-MD
- Primary DI / UDI-DI
- 00850018342438
- Basic UDI-DI
- 850018342TOPXLHDTA
- Direct Marketing DI
- 00850018342438
- EMDN Code
- Y210603 Video magnifiers
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000037119
- Authorised representative
- Optelec Nederland B.V. NL-AR-000035613
Other devices from Freedom Scientific Blv Group, LLC.
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