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TheraBand, 5’, Blue
EUDAMEDClass I (EU MDR)
Ref 20253Model Resistance BandsRef 20550
Identity
- Trade Name
- TheraBand, 5’, Blue EUDAMEDTheraband, 5’ Dispenser Pack, Blue EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED20253 EUDAMED20550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453202533 EUDAMED00087453205503 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
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
TheraBand, 5’, Blue 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 26e8564d-b9c3-4681-ab25-2cd63b7b5640 61 fields · synced Jul 17, 2026
- EUDAMED 305bfd9f-da3a-448e-82e9-6ddea85b79ed 61 fields · synced May 17, 2026