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ACIST Pro Accessories
EUDAMEDClass I (EU MDR)
Ref ACIST Pro Hemodynamic CableModel ACIST Pro
Identity
- Device Name
- ACIST Pro Accessories EUDAMED
- Model / Reference
- ACIST Pro EUDAMEDACIST Pro Hemodynamic Cable EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716103008 EUDAMED
- Basic UDI-DI
- 08417161000016G2 EUDAMED
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ACIST Pro Accessories by ACIST Medical Systems, Inc. — Class I — 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 | 08417161000016G2 | Class I | 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 (1)
- EUDAMED df5af138-1d61-4d2e-b2de-2c85997cd9c6 61 fields · synced Jun 19, 2026