Identity
- Trade Name
- Neonatal Sensors EUDAMED
- Device Name
- Neonatal Hydrogel Sensor, OBM positioning strips EUDAMED
- Model / Reference
- CZA00037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830007443 EUDAMED
- Basic UDI-DI
- 038383NA00019F5 EUDAMED
- Direct Marketing DI
- 00382830007443 EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER 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
Neonatal 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 | 038383NA00019F5 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED 4f21563c-34e7-46b3-ac80-6892fd21b2f0 61 fields · synced Jun 18, 2026