Identity
- Trade Name
- Dyaco EUDAMED
- Device Name
- Rehabilitation bike EUDAMED
- Model / Reference
- 7.0R EUDAMEDMR490 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710004758765 EUDAMED
- Basic UDI-DI
- B-04710004758765 EUDAMED471000475BKM3 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
Category: Rubber dam, Hevea-latex
Dyaco by Dyaco International Inc. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rubber dam, Hevea-latex.
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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-04710004758765 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04710004758765 | 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 (2)
- EUDAMED 24e943b5-abd6-4f14-937f-f4f9d3ebcc22 61 fields · synced Jul 31, 2026
- EUDAMED 84c02a1d-7f83-46dd-85c1-8b9c2dfeaeb9 61 fields · synced May 17, 2026