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Rolyan Exercise Band, Level 5, Non-Latex, 1.5M - Black
EUDAMEDClass I (EU MDR)
Ref 091192004Model Resistance BandsRef 091338938
Identity
- Trade Name
- Rolyan Exercise Band, Level 5, Non-Latex, 1.5M - Black EUDAMEDRolyan Exercise Band, Level 5, Non-Latex, 5M - Black EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED091192004 EUDAMED091338938 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453800449 EUDAMED05028319066772 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
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
Rolyan Exercise Band, Level 5, Non-Latex, 1.5M - Black by The Hygenic Company, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 0a006367-9eab-4972-8eca-83881822dce6 61 fields · synced Jul 20, 2026
- EUDAMED 0052e7fd-3c6c-4efd-922d-3691d7ce2dbd 61 fields · synced May 18, 2026