Brillenwerk von Optik Sutter
by Optik Sutter e.U. 6 variants
Ref BW01-M-53, BW01-M-47, BW01-M-49, BW01-M-58, BW01-M-50, BW01-M-51, BW01-M-52, BW01-M-48
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 | Number912014381BWOS014W | 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- Withdrawn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
- Optik Sutter Brillenwerk 3D-Fassungen (BWSO01)
- Model / Reference
- BW01-M-53, BW01-M-47, BW01-M-49, BW01-M-58, BW01-M-50, BW01-M-51, BW01-M-52, BW01-M-48
- Primary DI / UDI-DI
- 09120143810098, 09120143810036, 09120143810050, 09120143810142, 09120143810067, 09120143810074, 09120143810081, 09120143810043
- Basic UDI-DI
- 912014381BWOS014W
- EMDN Code
- Q02100202 Plastic spectacle frames without lenses
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000052724
Other devices from Optik Sutter e.U.
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