Identity
- Trade Name
- ACIST CVi BT2000 MANIFOLD KIT EUDAMED
- Device Name
- A2000 SYRINGE KIT EUDAMED
- Model / Reference
- 014612 EUDAMED014613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716103176 EUDAMED
- Basic UDI-DI
- 08417161000002FP EUDAMED
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ACIST CVi BT2000 MANIFOLD KIT by ACIST Medical Systems, Inc. — Class IIa — 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 | 08417161000002FP | Class IIa | 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 8dfe57de-a9d6-452f-bd17-88ec9ec4383a 61 fields · synced Jul 16, 2026