Identity
- Trade Name
- Dyaco EUDAMED
- Device Name
- Rehabilitation treadmill EUDAMED
- Model / Reference
- 7.0T EUDAMEDMT8000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710004758758 EUDAMED
- Basic UDI-DI
- B-04710004758758 EUDAMED471000475TMNV EUDAMED
- EMDN Code
- Y050201,Y0504 EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dyaco by Dyaco International Inc. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04710004758758 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04710004758758 | Class IIa | 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 (2)
- EUDAMED 4a082cca-7cf5-4ce7-81e2-706cd7a0818c 61 fields · synced Aug 1, 2026
- EUDAMED b2f45fcc-e5be-45f0-8cb4-d4d4aca84f71 61 fields · synced May 19, 2026