Artix MT, MT8
by Inari Medical, Inc. United States EUDAMEDGUDID
Ref 32-103Model 31-101
Product code QEWEMDN C010402020702
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number081012371ARTIXCT76 | Date30 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810123710591 | Date11 Nov 2024 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Artix MT, MT8 EUDAMEDArtix MT GUDID
- Generic Name
- Thrombectomy wire-net
- Device Name
- Artix AX, 85 cm
- Model / Ref / Catalog
- 31-101, 32-103, 32-103 / AS-01244
- Primary DI / UDI-DI
- 00810123710591
- Basic UDI-DI
- 081012371ARTIXCT76
- Direct Marketing DI
- 00810123710591
- FDA Product Code
- QEW, KRA, DQY
- EMDN Code
- C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
- GMDN Term
- Thrombectomy wire-net
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.5150, 870.1210, 870.1250
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 31-101 32-103 | 32-103 / AS-01244 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000008693
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Inari Medical, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 0e755f1f-99c8-454d-aac9-71caad476f8f
- FDA UDI 67379e43-d86b-4c7b-8153-d81edad2934b