Immosoft
Ref IM11DModel IMMOSOFT
Immosoft (IM11D) is a Class I device made by Orthosoft, registered in EUDAMED on 20 Apr 2022 (Basic UDI-DI 37602703434010774557G), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number37602703434010774557G 03760270340219 | Date20 Apr 2022 | StatusActive |
Official records
- EUDAMED public site 37602703434010774557G
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- Withdrawn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
- Model / reference
- IMMOSOFT, IM11D
- Primary DI / UDI-DI
- 03760270340219
- Basic UDI-DI
- 37602703434010774557G
- EMDN code
- Y060612 Wrist-hand orthoses
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000216
Similar devices in this category
Other devices filed under WRIST-HAND ORTHOSES.
- Arthritis Gloves AG-13 by Shenzhen QiJiang Technology Co., Ltd
- Ortéza zápästia, laminovaný materiál, ZA-51, ľavá 8585003406759 by PROTETIKA, a.s.
- SELECTION WRIST ORTHOSIS RIGID 352061014 by Camp Scandinavia AB
- Ortéza zápästia, laminovaný materiál, ZA-52, ľavá 8585003410367 by PROTETIKA, a.s.
- Miracle 6222012004294 by Miracle Medical Industries
- FYN WRIST by GROUPE SOBER SAS
- STABIPOIGNET 3D by GROUPE SOBER SAS
- Post Operative Carpal Sleeve, Large, Left 14135 by Silipos Holding LLC.
- LACE-UP WRIST SPLINT ARH19FB by HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ
- The Boxer Orthosis 00950-10R-01 by Professional Products, Inc.