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Rolyan Exercise Band, Level 4, Latex, 1.5M - Blue
EUDAMEDClass I (EU MDR)
Ref 091191964Model Resistance BandsRef 091191998
Identity
- Trade Name
- Rolyan Exercise Band, Level 4, Latex, 1.5M - Blue EUDAMEDRolyan Exercise Band, Level 4, Non-Latex, 1.5M - Blue EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED091191964 EUDAMED091191998 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453800388 EUDAMED00087453800432 EUDAMED
- Basic UDI-DI
- 00874530000000000000001XH 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
EUDAMEDEUDAMED
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 4, Latex, 1.5M - Blue 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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- Non-Latex .18/.23mm Medium Royal Blue 6”x 6“ 15pcs — Four D Rubber Company Ltd · Class I
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- HYGENIC — Coltene/Whaledent Inc. · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · Class I
- SISSEL® FITBAND PLUS 5m red — SISSEL GmbH · 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 | 00874530000000000000001XH | Class I | Active |
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Manufacturer
- Manufacturer
- The Hygenic Company, LLC
- EUDAMED SRN
- US-MF-000003317
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 8958315b-7f9d-4552-bd3c-6879e3246e7c 61 fields · synced Jul 15, 2026
- EUDAMED 857b8336-84b0-430b-b9e3-606693dc3def 61 fields · synced May 18, 2026