Identity
- Trade Name
- ACIST Pro EUDAMEDRXi® Cable FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Device Name
- ACIST Pro Accessories EUDAMEDRXi Medex cable, p/n 301831-001 FDA UDI
- Model / Reference
- ACIST Pro EUDAMED016217 EUDAMEDFDA UDI
- Description
- RXi Medex cable, p/n 301831-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30841716102012 EUDAMEDFDA UDI
- Basic UDI-DI
- 08417161000019G8 EUDAMED
- 510(k) Number
- K132474 FDA UDI
- FDA Product Code
- OBI FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Cardiac catheterization laboratory computer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electromagnetic surgical navigation device tracking system
ACIST Pro by ACIST Medical Systems, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic surgical navigation device tracking system.
- RTM 92 HS — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. · Class IIb
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- IA091S — ALFAMED SRL · Class IIa
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Needle Holder — Shandong Chengwu Medical Products Factory · Class I
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- Nadeln / Needles — REDA Instrumente GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08417161000019G8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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 (2)
- EUDAMED 318e15c6-1126-4c28-b510-d68a01eacd22 61 fields · synced Jun 8, 2026
- FDA UDI 6a1c65e7-ecb1-4643-a1d7-2f40059c64a4 34 fields · synced May 30, 2026