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TheraBand 12” Resistance Band Loop, Gold
EUDAMEDClass I (EU MDR)
Ref 15453Model Resistance Bands
Identity
- Trade Name
- TheraBand 12” Resistance Band Loop, Gold EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED15453 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453154535 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
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
TheraBand 12” Resistance Band Loop, Gold 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 (1)
- EUDAMED 86461bbb-65f6-49d7-ad85-5d772cf55d5d 61 fields · synced Jun 17, 2026