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ACIST Pro
EUDAMEDClass IIb (EU MDR)
Ref 019304Model ACIST Pro SystemRef 019312Ref 019305Model ACIST ProRef 019257
Identity
- Trade Name
- ACIST Pro EUDAMED
- Device Name
- ACIST Pro Diagnostic System EUDAMEDACIST Pro Accessories EUDAMED
- Model / Reference
- ACIST Pro System EUDAMED019304 EUDAMED019312 EUDAMEDACIST Pro EUDAMED019305 EUDAMED019257 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716103084 EUDAMED10841716103664 EUDAMED10841716103916 EUDAMED10841716103909 EUDAMED
- Basic UDI-DI
- 08417161000014FW EUDAMED08417161000016G2 EUDAMED
- Direct Marketing DI
- 10841716103084 EUDAMED10841716103664 EUDAMED10841716103916 EUDAMED10841716103909 EUDAMED
- EMDN Code
- Z11039013 ANGIOGRAPHIC INJECTORS EUDAMEDZ11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMEDEUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
ACIST Pro by ACIST Medical Systems, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08417161000014FW | Class IIb | Active |
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Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000010784
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (4)
- EUDAMED 8a1e5753-cf40-4214-b182-62cebf493a97 61 fields · synced Jul 20, 2026
- EUDAMED 12866f2f-df5a-4bc8-8f9c-b98ccf78dd5c 61 fields · synced May 16, 2026
- EUDAMED 76b8005b-abd6-4f7e-a851-1a046fd5cd59 61 fields · synced May 16, 2026
- EUDAMED d619d00f-dc7b-47d8-9ff5-230358514131 61 fields · synced May 18, 2026