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Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black
EUDAMEDClass I (EU MDR)
Ref 091337385Model Resistance Bands
Identity
- Trade Name
- Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED091337385 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453800548 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
Category: Rubber dam, Hevea-latex
Rolyan Exercise Band, Level 5, Non-Latex, 25M - Black by The Hygenic Company, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rubber dam, Hevea-latex.
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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 (1)
- EUDAMED 53be0e94-f2c5-42b7-9a00-208703a58ca2 61 fields · synced Jun 18, 2026