Identity
- Trade Name
- Thumb Spica Splint EUDAMED
- Device Name
- Dyna Thumb Spica Splint EUDAMED
- Model / Reference
- 1655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044240755 EUDAMED
- Basic UDI-DI
- 890404421655DK EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Thumb Spica Splint by Dynamic Techno Medicals Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890404421655DK | Class I | Active |
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Manufacturer
- Manufacturer
- Dynamic Techno Medicals Pvt Ltd
- EUDAMED SRN
- IN-MF-000017845
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d0b60ed7-b4d3-4c09-805e-f1372eab485a 61 fields · synced Jul 21, 2026