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Rolyan Exercise Band, Level 3, Latex, 25M - Green
EUDAMEDClass I (EU MDR)
Ref 091259654Model Resistance BandsRef THA-METBAND25MGRNRef 091337369
Identity
- Trade Name
- Rolyan Exercise Band, Level 3, Latex, 25M - Green EUDAMEDRolyan Exercise Band, Level 3, Non-Latex, 25M - Green EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED091259654 EUDAMEDTHA-METBAND25MGRN EUDAMED091337369 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453800470 EUDAMED05028319065201 EUDAMED00087453800524 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
Rolyan Exercise Band, Level 3, Latex, 25M - Green 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 (3)
- EUDAMED 45014f9a-42f3-4b7f-ab23-789333507bf5 61 fields · synced Jul 13, 2026
- EUDAMED af51efa6-5842-4b89-b768-19498e5ee46a 61 fields · synced May 18, 2026
- EUDAMED 4b96ce98-4042-44fb-b6f5-8823aa5a1178 61 fields · synced May 19, 2026