Occlutech PDA Occluder Procedure Pack
by Occlutech International AB 13 variants
Ref 43PDA10LO
Active
CE MDR
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/MDR | Number73401756PDAOOPJP | Date21 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 43PDA10LO
- Primary DI / UDI-DI
- 07340175605116, 07340175600722
- Basic UDI-DI
- 73401756PDAOOPJP
- EMDN Code
- P07040303 Cardiac occluders, foramen ovale and botallo duct
- Device Class
- Class III
- Medical Purpose
- The Occlutech PDA Occluder is a percutaneous transcatheter medical device for the non-surgical closure of Patent Ductus Arteriosus (PDA).
Manufacturer details
- EUDAMED SRN
- SE-PR-000017759
Other devices from Occlutech International AB
Properties
Other properties (1)
- Sterile: No