Silmäproteesit Lehto & Sohlberg Oy
by IsoDent Oy
Ref 6430043960728
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 | Number6430043966430043960728XE 06430043960728 | Date22 Nov 2023 | 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- Withdrawn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
- Eye prostheses Lehto & Sohlberg Oy
- Model / Reference
- 6430043960728
- Primary DI / UDI-DI
- 06430043960728
- Basic UDI-DI
- 6430043966430043960728XE
- EMDN Code
- P0399 Ocular prostheses - other
- Device Class
- Class I
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000023346
Other devices from IsoDent Oy
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