Identity
- Trade Name
- Dyaco EUDAMED
- Device Name
- Rehabilitation bike EUDAMED
- Model / Reference
- 8.0U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710004759007 EUDAMED
- Basic UDI-DI
- 471000475BKM3 EUDAMED
- Direct Marketing DI
- 04710004759007 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 — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, Hevea-latex.
- ISOTEX Band - Blueberry - 0.30mm - 1.5M - Latex Dispenser — Four D Rubber Company Ltd · Class I
- Theraband, Tubing with Hard Handles, Green — The Hygenic Company, LLC · Class I
- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- TheraBand Exercise Band 2.5m Yellow in Zipper Bag with Retail Carton - EU — The Hygenic Company, LLC · Class I
- BANCO DE COLSON (2 PLAZAS) — ORTOTECSA,S.L. · Class I
- Non-Latex .18/.23mm Medium Royal Blue 6”x 6“ 15pcs — Four D Rubber Company Ltd · Class I
- LATEX FREE .23/.28mm Heavy - D. Blue 6" x 6" 20pcs — Four D Rubber Company Ltd · Class I
- Theraband 25 Yard Non-Latex Black CE Mark — The Hygenic Company, LLC · Class I
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 | 471000475BKM3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dyaco International Inc.
- EUDAMED SRN
- TW-MF-000034151
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED 878a5087-2408-4858-8bba-2a0607e0d519 61 fields · synced Jun 18, 2026