Identity
- Trade Name
- Flexicouplers and Jelly Tab Sensors EUDAMED
- Device Name
- 20 PKG/60 Count Tab Electrode Package EUDAMED
- Model / Reference
- 101661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830001045 EUDAMED
- Basic UDI-DI
- 038283NA00108E8 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS 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
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
Flexicouplers and Jelly Tab Sensors by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — 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 | 038283NA00108E8 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED 7f8892c5-7520-4742-8361-e981684806a5 61 fields · synced Jun 19, 2026