Identity
- Trade Name
- DOPPLEX EUDAMEDFDA UDI
- Generic Name
- Invasive vascular ultrasound system probe FDA UDI
- Device Name
- 3 WAY IEC PATIENT CABLE EUDAMEDPROBE ADAPTOR PA8 - HG FDA UDI
- Model / Reference
- ACC-VSM-213 EUDAMEDPA8-HG EUDAMEDFDA UDI
- Description
- PROBE ADAPTOR PA8 - HG FDA UDI
Identifiers
- Catalog Number
- PA8-HG FDA UDI
- Primary DI / UDI-DI
- 05051968022981 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520464WM EUDAMED
- 510(k) Number
- K032315 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Invasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 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
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
Category: Ultrasonic surgical system generator
Dopplex by Arjohuntleigh AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 5060693520464WM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED 2c820b91-9242-4d82-ac0d-7eff6f70686a 61 fields · synced Jun 18, 2026
- FDA UDI c4e122ee-439c-4db3-9d00-bdf9006b6944 37 fields · synced May 30, 2026