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ISOTEX Band - Plum- 0.35mm - 45.7M - Non-Latex
EUDAMEDClass I (EU MDR)
Ref BANDSLFDJOPLU45710000Model Lifestyle - Exercise BandRef BANDSLAITXPLU45712800
Identity
- Trade Name
- ISOTEX Band - Plum- 0.35mm - 45.7M - Non-Latex EUDAMEDISOTEX Band - Plum- 0.35mm - 45.7M - Latex EUDAMED
- Model / Reference
- Lifestyle - Exercise Band EUDAMEDBANDSLFDJOPLU45710000 EUDAMEDBANDSLAITXPLU45712800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060748681072 EUDAMED05060748680396 EUDAMED
- Basic UDI-DI
- 506074868NLLSFD EUDAMED506074868LALSD8 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
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
Category: Rubber dam, Hevea-latex
ISOTEX Band - Plum- 0.35mm - 45.7M - Non-Latex 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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- 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 dc38b14e-a19d-442c-8db4-702b044660b1 61 fields · synced Oct 6, 2026
- EUDAMED 98f9a298-fabe-458a-b64d-5446b51f4ea0 61 fields · synced Jul 10, 2026