Digistrap
Ref DIGISTRAPModel ATTELLE DE DOIGTS (SYNDACTYLIE)
Digistrap is a Class I device made by Groupe Sober SAS, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI B-03701459802432), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-03701459802432 | Date10 Jul 2026 | StatusActive |
Official records
- EUDAMED public site B-03701459802432
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- Withdrawn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/MDD Active
Specification
- Model / reference
- ATTELLE DE DOIGTS (SYNDACTYLIE), DIGISTRAP
- Primary DI / UDI-DI
- 03701459802432, 03701459802418, 03701459802425, 03701459802401
- Basic UDI-DI
- B-03701459802432, B-03701459802418, B-03701459802425, B-03701459802401
- EMDN code
- Y060603 Fingers orthoses
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000017818
Similar devices in this category
Other devices filed under FINGERS ORTHOSES.
- FINGER SPLINT 9.5*3.5*2.5cm by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- BASIC THUMB ORTHOSIS SHORT 274431011 by Camp Scandinavia AB
- SELECTION THUMB ORTHOSIS SOFT 352002012 by Camp Scandinavia AB
- MQ505 OTTEC 16720141002 by ESPECIALIDADES MÉDICO ORTOPEDICAS,S.L.
- Finger Brace FB-22 by Shenzhen QiJiang Technology Co., Ltd
- Finger Brace HB-212 by Shenzhen QiJiang Technology Co., Ltd
- ΝΑΡΘΗΚΑΣ ΚΑΡΠΟΥ & ΑΝΤΙΒΡΑΧΙΟΥ air mesh 0514 by ΑΝΑΤΟΜΙΚ ΧΕΛΠ ΑΝΩΝΥΜΗ ΕΤΑΙΡΙΑ ΕΜΠΟΡΙΑΣ ΚΑΙ ΚΑΤΑΣΚΕΥΗΣ ΟΡΘΟΠΕΔΙΚΩΝ ΕΙΔΩΝ Α.Ε.
- ΝΑΡΘΗΚΑΣ ΔΑΚΤΥΛΟΥ ΤΥΠΟΥ "BASEBALL" 0254 by ΑΝΑΤΟΜΙΚ ΧΕΛΠ ΑΝΩΝΥΜΗ ΕΤΑΙΡΙΑ ΕΜΠΟΡΙΑΣ ΚΑΙ ΚΑΤΑΣΚΕΥΗΣ ΟΡΘΟΠΕΔΙΚΩΝ ΕΙΔΩΝ Α.Ε.
- Finger Splint PM12062 by Ningbo Pinmed Instruments Co., Ltd.
- Splints EJB-001E by SHANGHAI EMSS MED&TECH CO.,LTD