← Back to catalogue
ISOTEX Band - Blue - 0.30mm - 1.5M - Latex Dispenser
EUDAMEDClass I (EU MDR)
Ref BANDSLAITXBLU01512830Model Lifestyle - Exercise BandRef BANDSLAITXBLU01512800
Identity
- Trade Name
- ISOTEX Band - Blue - 0.30mm - 1.5M - Latex Dispenser EUDAMEDISOTEX Band - Blue - 0.30mm - 1.5M - Latex EUDAMED
- Model / Reference
- Lifestyle - Exercise Band EUDAMEDBANDSLAITXBLU01512830 EUDAMEDBANDSLAITXBLU01512800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060748680099 EUDAMED05060748680082 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
ISOTEX Band - Blue - 0.30mm - 1.5M - Latex Dispenser by Four D Rubber Company Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 c9c04515-1a47-4312-a276-593b15745929 61 fields · synced Oct 6, 2026
- EUDAMED c6ea1742-0cfb-4070-946a-34cb8e17c738 61 fields · synced May 18, 2026