P PTZ HD ErgoJust Video Extension
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- P PTZ HD ErgoJust Video Extension EUDAMEDErgoJust LTM & ICU FDA UDI
- Generic Name
- Examination/operating table component trolley FDA UDI
- Device Name
- Natus ErgoJust LTM and ErgoJust ICU carts EUDAMEDIP PTZ HD ErgoJust Video Extension FDA UDI
- Model / Reference
- IP-HD-EC-VIDEO-EXT EUDAMEDFDA UDI
- Description
- IP PTZ HD ErgoJust Video Extension FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830058384 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00106E4 EUDAMED
- Direct Marketing DI
- 00382830058384 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Examination/operating table component trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
P PTZ HD ErgoJust Video Extension by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038283NA00106E4 | 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 9cc5fa35-88eb-473c-b07f-58e425cead20 61 fields · synced Jun 19, 2026
- FDA UDI 36f52b7d-f3fb-449c-9a30-c5944f136aa3 33 fields · synced May 30, 2026