FlexCath Cross Transseptal Solution
by Acutus Medical, Inc. United States EUDAMED
Ref 900307
EMDN C01020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000165613 | Date22 Feb 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 1000166386 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 22 Feb 2024
- Expires
- 21 Feb 2029
- 1000165613 Issued
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 22 Feb 2024
- Expires
- 14 Nov 2027
Specification
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle
- Model / Reference
- 900307
- Primary DI / UDI-DI
- 00850027837895
- Basic UDI-DI
- 0850027837ACQCROSSP3
- EMDN Code
- C01020101 Central i.v. single-lumen catheters, peripheral access
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000019413
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Acutus Medical, Inc.
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 369b665b-5638-40f8-b35f-4c85202bd35b