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ISOTEX Band - Peach - 0.16mm 5.5M - Latex
EUDAMEDClass I (EU MDR)
Ref BANDSLAITXPCH05512800Model Lifestyle - Exercise Band
Identity
- Trade Name
- ISOTEX Band - Peach - 0.16mm 5.5M - Latex EUDAMED
- Model / Reference
- Lifestyle - Exercise Band EUDAMEDBANDSLAITXPCH05512800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060748680341 EUDAMED
- Basic UDI-DI
- 506074868LALSD8 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
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
ISOTEX Band - Peach - 0.16mm 5.5M - 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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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 | 506074868LALSD8 | 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 (1)
- EUDAMED d22bddf7-db1d-4e27-a54b-a579d40f823d 61 fields · synced Jul 15, 2026