Identity
- Trade Name
- Ultra Pro Ultrasound Table 230V EUDAMEDUltra Pro Ultrasound Table, 230V FDA UDI
- Generic Name
- Ultrasound imaging system table, powered FDA UDI
- Device Name
- Ultrasound Tables EUDAMEDFully equipped for OB/GYN, and general ultrasound with extra-wide tabletop. Includes hand and optional foot controllers to activate height, Trendelenburg motions and Fowler positioning. FDA UDI
- Model / Reference
- 058-725 EUDAMEDFDA UDI
- Description
- Fully equipped for OB/GYN, and general ultrasound with extra-wide tabletop. Includes hand and optional foot controllers to activate height, Trendelenburg motions and Fowler positioning. FDA UDI
Identifiers
- Catalog Number
- 058-725 FDA UDI
- Primary DI / UDI-DI
- 00879942070644 EUDAMEDFDA UDI
- Basic UDI-DI
- 085994200610858 EUDAMED
- Direct Marketing DI
- 00879942070644 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Ultrasound imaging system table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Northern 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
Ultra Pro Ultrasound Table 230V by Mirion Technologies (Capintec), Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 085994200610858 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED e00e61bb-4f1d-491c-9c58-cf3c6574a1f6 61 fields · synced Jun 18, 2026
- FDA UDI 4fd01b1c-09bb-4ad6-8128-5afdbda24f4c 35 fields · synced May 30, 2026