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THERABAND Shoulder Pulley
EUDAMEDClass I (EU MDR)
Ref 27313Model Resistance BandsRef 52161
Identity
- Trade Name
- THERABAND Shoulder Pulley EUDAMED
- Device Name
- Resistance Accessory EUDAMED
- Model / Reference
- Resistance Bands EUDAMED27313 EUDAMED52161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453273137 EUDAMED00087453521610 EUDAMED
- Basic UDI-DI
- 00874530000000000000003XM 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
THERABAND Shoulder Pulley by The Hygenic Company, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 00874530000000000000003XM | 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 ace0f1bb-55a9-4259-8a18-58eb47976e9a 61 fields · synced Oct 6, 2026
- EUDAMED c1a729e2-fdb9-4ef0-811b-596116d47f63 61 fields · synced May 19, 2026