Identity
- Trade Name
- IS5LED Record Indicator - Plastic connector EUDAMED
- Device Name
- Data Acquisition Systems (Accessories) EUDAMED
- Model / Reference
- IS5LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060481691727 EUDAMED
- Basic UDI-DI
- 506048169AccessoriesRSU2 EUDAMED
- EMDN Code
- Z12062480 BIOFEEDBACK INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
IS5LED Record Indicator - Plastic connector by Biometrics 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 | 506048169AccessoriesRSU2 | Class I | Active |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 91b03a18-d718-479d-bd69-a022bdd38f59 61 fields · synced Jul 20, 2026