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TheraBand Latex Free Beginner Pack – International
EUDAMEDClass I (EU MDR)
Ref 11883Model Resistance Bands
Identity
- Trade Name
- TheraBand Latex Free Beginner Pack – International EUDAMED
- Device Name
- TheraBands EUDAMED
- Model / Reference
- Resistance Bands EUDAMED11883 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453118834 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
TheraBand Latex Free Beginner Pack – International 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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- HEDY DENTAL DAM — AMD Medicom Inc · Class I
- SISSEL® FITBAND PLUS 5m red — SISSEL GmbH · Class I
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 9f5c4c7a-bd55-4e15-bbed-0c45e6ce256e 61 fields · synced Jul 9, 2026