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ISOTEX Band - Green- 0.25mm - 1.5M - Non-Latex Dispenser
EUDAMEDClass I (EU MDR)
Ref BANDSLFITXGRN01510030Model Lifestyle - Exercise BandRef BANDSLFITXGRN01510000
Identity
- Trade Name
- ISOTEX Band - Green- 0.25mm - 1.5M - Non-Latex Dispenser EUDAMEDISOTEX Band - Green- 0.25mm - 1.5M - Non-Latex EUDAMED
- Model / Reference
- Lifestyle - Exercise Band EUDAMEDBANDSLFITXGRN01510030 EUDAMEDBANDSLFITXGRN01510000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060748681218 EUDAMED05060748681201 EUDAMED
- Basic UDI-DI
- 506074868NLLSFD EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
ISOTEX Band - Green- 0.25mm - 1.5M - Non-Latex Dispenser by Four D Rubber Company Ltd — 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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- Theraband 25 Yard Non-Latex Black CE Mark — The Hygenic Company, LLC · Class I
- HYGENIC — Coltene/Whaledent Inc. · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · 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 | 506074868NLLSFD | Class I | Active |
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Manufacturer
- Manufacturer
- Four D Rubber Company Ltd
- EUDAMED SRN
- GB-MF-000012178
- Authorised Representative
- DEVMED International Limited IE-AR-000011607
Sources (2)
- EUDAMED 6d99cb22-763f-455e-9fbe-6bd50dd7b24d 61 fields · synced Oct 6, 2026
- EUDAMED 90d7d8b9-da62-447c-89d0-188d21712039 61 fields · synced May 18, 2026