Identity
- Trade Name
- RXi Pd Cable EUDAMED
- Model / Reference
- RXi Accessories EUDAMED016217 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716102018 EUDAMED
- Basic UDI-DI
- 08417161000006FX EUDAMED
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
RXi Pd Cable 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 | 08417161000006FX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000010784
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (1)
- EUDAMED 05aed463-d996-4fab-a4f8-467cb4ff6d6c 61 fields · synced Jun 19, 2026