Identity
- Trade Name
- IS2LED Event Marker - Plastic connector EUDAMED
- Device Name
- Data Acquisition Systems (Accessories) EUDAMED
- Model / Reference
- IS2LED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060481691970 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
IS2LED Event Marker - 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 38c823ee-8358-4736-a15b-6f4e91648e80 61 fields · synced Jun 19, 2026