formoline L112 EXTRA
by Certmedica International GmbH EUDAMED
Active
Ref 14-750-16-04
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 109587 0002 | Date27 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Sweden since 6 Nov 2025
Certificates
- G70 109587 0002 Reissued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 27 Jul 2026
- Expires
- 7 Oct 2031
- Valid from
- 8 Oct 2026
Specification
- Device Name
- L112-Produktreihe
- Model / Reference
- 14-750-16-04
- Primary DI / UDI-DI
- 04260103335195, 04260103334389, 04260103334570, 04260103335423, 04260103335447, 04260103335140, 04260103335430, 04260103334631, 04260103335478, 04260103335348, 04260103335515, 04260103335409, 04260103334402, 04260103335362
- Basic UDI-DI
- 426010333L112T4
- EMDN Code
- G030699 Devices for the non-surgical treatment of obesity - other
- Device Class
- Class III
- Market of Registration
- SpainGreecePortugalSwedenAustriaCzechiaItalyLuxembourgCroatiaIrelandLatviaDenmark
Manufacturer details
- EUDAMED SRN
- DE-MF-000006199
Other devices from Certmedica International GmbH
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No