← Back to catalogue
ISOTEX Band - Gold - 0.45mm - 1.5M - Latex
EUDAMEDClass I (EU MDR)
Ref BANDSLAITXGLD01512800Model Lifestyle - Exercise BandRef BANDSLAITXGLD01512830
Identity
- Trade Name
- ISOTEX Band - Gold - 0.45mm - 1.5M - Latex EUDAMEDISOTEX Band - Gold - 0.45mm - 1.5M - Latex Dispenser EUDAMED
- Model / Reference
- Lifestyle - Exercise Band EUDAMEDBANDSLAITXGLD01512800 EUDAMEDBANDSLAITXGLD01512830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060748680129 EUDAMED05060748680136 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 - Gold - 0.45mm - 1.5M - Latex by Four D Rubber Company Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, Hevea-latex.
- Theraband, Tubing with Hard Handles, Green — The Hygenic Company, LLC · Class I
- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- Medical Loops — Ningbo Jenius Polymer Sci-Tech Co.,Ltd · Class I
- TheraBand Exercise Band 2.5m Yellow in Zipper Bag with Retail Carton - EU — The Hygenic Company, LLC · Class I
- BANCO DE COLSON (2 PLAZAS) — ORTOTECSA,S.L. · Class I
- 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 | 506074868LALSD8 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Four D Rubber Company Ltd
- EUDAMED SRN
- GB-MF-000012178
- Authorised Representative
- DEVMED International Limited IE-AR-000011607
Sources (2)
- EUDAMED 3f09f032-8e29-467f-b9a2-34ef574bf7dc 61 fields · synced Oct 6, 2026
- EUDAMED 0e340670-513b-4f74-926c-3811860d31e3 61 fields · synced May 18, 2026