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Rolyan Exercise Band, Level 1, Latex, 30.5M - Yellow
EUDAMEDClass I (EU MDR)
Ref 091170323Model RESISTANCE BANDS
Identity
- Trade Name
- Rolyan Exercise Band, Level 1, Latex, 30.5M - Yellow EUDAMED
- Device Name
- TUBING EUDAMED
- Model / Reference
- RESISTANCE BANDS EUDAMED091170323 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453800302 EUDAMED
- Basic UDI-DI
- 00874530000000000000002XK EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Rubber dam, Hevea-latex
Rolyan Exercise Band, Level 1, Latex, 30.5M - Yellow by The Hygenic Company, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, Hevea-latex.
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- 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
- HYGENIC — Coltene/Whaledent Inc. · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · 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 | 00874530000000000000002XK | Class I | Active |
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Manufacturer
- Manufacturer
- The Hygenic Company, LLC
- EUDAMED SRN
- US-MF-000003317
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 28ee0ba5-c0a6-4343-b916-5ccdd1d88366 61 fields · synced Oct 6, 2026