Monotime®
by Advanced Medical Solutions (France) SAS 140 variants
Part of a family of 140 devices: see the family page
Ref 14S15F
Monotime® (14S15F) is a Class III device made by Advanced Medical Solutions (France) SAS, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 3661522DTSU2001VT), active as of 7 Nov 2026.
Active
CE MDR CE MDD
Valid until
3 Apr 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number3661522DTSU2001VT 03661522021934 | Date20 Aug 2026 | StatusActive |
| European Union | CE/MDR | Number3661522DTSU2001VT 03661522021934 | Date20 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 3661522DTSU2001VT
Certificates
- 39667 Active
Technical documentation EU MDR
- Certifier
- GMED SAS 0459
- Issued
- 22 Jul 2026
- Expires
- 3 Apr 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Monotime
- Model / reference
- 14S15F
- Primary DI / UDI-DI
- 03661522021934
- Basic UDI-DI
- 3661522DTSU2001VT, B-03661522021934
- EMDN code
- H010101010101, H010101010102
- Device class
- Class III
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000666
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