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TheraBand 12” Multi-Color 3Pk Loop Blk/Sil/Gold Latex
EUDAMEDClass I (EU MDR)
Ref 15455Model Resistance BandsRef 15456
Identity
- Trade Name
- TheraBand 12” Multi-Color 3Pk Loop Blk/Sil/Gold Latex EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED15455 EUDAMED15456 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453154559 EUDAMED00087453154566 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
Category: Rubber dam, Hevea-latex
TheraBand 12” Multi-Color 3Pk Loop Blk/Sil/Gold Latex 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 (2)
- EUDAMED 88150b5d-4542-44a4-ac45-74b72e023515 61 fields · synced Jul 31, 2026
- EUDAMED b2bd8cfe-b864-4a26-a38d-d0a616c6f09c 61 fields · synced May 18, 2026