UltraFlex(TM) IAB
by Arrow International LLC (Subsidiary of Teleflex Incorporated) United States EUDAMED
Ref IAB-06850-U
EMDN C019001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-10801902172911 | Date4 Aug 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- UltraFlex IAB: 8Fr 50cc
- Model / Reference
- IAB-06850-U
- Primary DI / UDI-DI
- 10801902172911
- Basic UDI-DI
- B-10801902172911
- EMDN Code
- C019001 Aortic counterpulsation catheters
- Device Class
- Class III
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000024256
- Authorised representative
- Teleflex Medical IE-AR-000015869
Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED 10801902172911|B-10801902172911