RediGuard(R) IAB
by Arrow International LLC (Subsidiary of Teleflex Incorporated) 2 variants
Ref IAB-S850C
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-10801902172959 10801902172959 | Date4 Aug 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- RediGuard IAB: 8Fr 50cc
- Model / Reference
- IAB-S850C
- Primary DI / UDI-DI
- 10801902172959
- Basic UDI-DI
- B-10801902172959
- EMDN Code
- C019001 Aortic counterpulsation catheters
- Device Class
- Class III
- EU 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)
See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →
Properties
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