Smartscope
by Optomed Oyj Finland EUDAMED
Ref 41000023, 41000032, 41000661, 31000054, 41000036Model Smartscope
EMDN Z119007
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06430046260139 | Date29 May 2024 | StatusActive |
| European Union | CE/MDD | NumberB-06430046260139 | Date29 May 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- SmartscopeOptomed Smartscope
- Device Name
- Smartscope ES2Smartscope Cradle V1Smartscope EY80Smartscope M5Smartscope EY4
- Model / Reference
- Smartscope, 41000023, 41000032, 41000661, 31000054, 41000036
- Primary DI / UDI-DI
- 06430046260139, 06430046262300, 06430046261020, 06430046263000, 06430046264007
- Basic UDI-DI
- B-06430046260139, 643004626cradle15BT, B-06430046261020, B-06430046263000, B-06430046264007
- EMDN Code
- Z119007, Z119080, Z119003
- Device Class
- Class IClass IIa
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000009407
Other devices from Optomed Oyj
Properties & raw data
Show properties, registry sources and raw records
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
Sources (5)
- EUDAMED 57eb11d7-9e4d-4b5f-baa4-8d2b5b0619a5
- EUDAMED 06430046262300|643004626CRADLE15BT
- EUDAMED 06430046261020|B-06430046261020
- EUDAMED 06430046263000|B-06430046263000
- EUDAMED 06430046264007|B-06430046264007