Identity
- Trade Name
- ACIST HDi® Cart FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- HDi Cart, p/n 205046-006 FDA UDI
- Model / Reference
- HDi Accessories EUDAMED017991 EUDAMEDFDA UDI
- Description
- HDi Cart, p/n 205046-006 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716102643 EUDAMEDFDA UDI
- Basic UDI-DI
- 08417161000009G5 EUDAMED
- 510(k) Number
- K193183 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
017991 by ACIST Medical Systems, 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 | 08417161000009G5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000010784
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (2)
- EUDAMED 3c689475-83ce-419b-ba43-cc20bea29698 61 fields · synced Jul 9, 2026
- FDA UDI 875fd422-8e4f-40a9-ba94-dac043acf082 34 fields · synced May 30, 2026