Identity
- Trade Name
- Breath Wrist Splint Right Large EUDAMED
- Device Name
- Dyna Breath Wrist Splint EUDAMED
- Model / Reference
- 1644 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044201770 EUDAMED
- Basic UDI-DI
- 890404421644DE EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Breath Wrist Splint Right Large 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 | 890404421644DE | 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 7fb7ac20-5f9f-4b46-b609-9bcac14f8ca4 61 fields · synced Jun 19, 2026