Identity
- Trade Name
- Dyaco EUDAMED
- Device Name
- Rehabilitation recumbent seated stepper EUDAMED
- Model / Reference
- 8.5S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710004759014 EUDAMED
- Basic UDI-DI
- 471000475STP8 EUDAMED
- Direct Marketing DI
- 04710004759014 EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dyaco by Dyaco International Inc. — 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 | 471000475STP8 | Class I | Active |
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Manufacturer
- Manufacturer
- Dyaco International Inc.
- EUDAMED SRN
- TW-MF-000034151
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED 2f69afb9-031c-4001-81e1-53d184c01889 61 fields · synced Jun 19, 2026