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H-Universal Stand
EUDAMEDFDA UDIClass I (EU MDR)
Ref P12163-16Model H-UNIVERSAL STAND
Identity
- Trade Name
- H-Universal Stand EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- H-UNIVERSAL STAND EUDAMEDDiagnostic Ultrasound System Accessory FDA UDI
- Model / Reference
- H-UNIVERSAL STAND EUDAMEDP12163-16 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound System Accessory FDA UDI
Identifiers
- Catalog Number
- P12163 FDA UDI
- Primary DI / UDI-DI
- 00841517102067 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517102067 EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI
- 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
H-Universal Stand by Fujifilm Sonosite, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841517102067 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED b8543573-3044-4505-ab45-542cb163e245 61 fields · synced Jul 17, 2026
- FDA UDI ef05feb4-f3e4-4491-9af0-c66247e75f1d 37 fields · synced May 30, 2026