Identity
- Trade Name
- Neonatal Hydrogel Sensor EUDAMEDNatus FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Neonatal Hydrogel Sensor, OBM positioning strips EUDAMEDOBM Positioning Strips FDA UDI
- Model / Reference
- OBM00047 EUDAMEDFDA UDI
- Description
- OBM Positioning Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830008679 EUDAMEDFDA UDI
- Basic UDI-DI
- 038383NA00019F5 EUDAMED
- Direct Marketing DI
- 00382830008679 EUDAMED
- FDA Product Code
- OMA FDA UDI
- EMDN Code
- N0101020101 EEG CORTICAL ELECTRODES EUDAMED
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Neonatal Hydrogel Sensor by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038383NA00019F5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 28aa6eca-44ad-4177-b2a2-f5c837a513a2 61 fields · synced Jul 9, 2026
- FDA UDI 5b2ea4d4-b20d-4ae3-9376-ab847f631b54 33 fields · synced May 30, 2026