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FHD IP PTZ Wall Mounted Camera Kit, INTL
EUDAMEDFDA UDIClass I (EU MDR)
Ref 022664
Identity
- Trade Name
- FHD IP PTZ Wall Mounted Camera Kit, INTL EUDAMEDNatus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Wall Mount Accessories EUDAMEDFHD IP PTZ Wall Mounted Camera Kit, INTL FDA UDI
- Model / Reference
- 022664 EUDAMEDFDA UDI
- Description
- FHD IP PTZ Wall Mounted Camera Kit, INTL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830059923 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00090EE EUDAMED
- Direct Marketing DI
- 00382830059923 EUDAMED
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electroencephalograph 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
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
FHD IP PTZ Wall Mounted Camera Kit, INTL 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 | 038283NA00090EE | 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 710b2386-d2eb-422a-981d-4ddec3db2a98 61 fields · synced Oct 6, 2026
- FDA UDI 09ff4d40-4ce9-42d3-ba9c-8750e77a5eb1 33 fields · synced May 30, 2026