Z-Med
Ref PDZ336Model 302.1
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-10887714014434 10887714014434 | Date19 Nov 2021 | 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- Withdrawn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
EU market availability
EUDAMED lists only past availability for this device:
- Austria (until 25 Feb 2024)
- Belgium (until 25 Feb 2024)
- Bulgaria (until 25 Feb 2024)
- Croatia (until 25 Feb 2024)
- Cyprus (until 25 Feb 2024)
- Czechia (until 25 Feb 2024)
- Denmark (until 25 Feb 2024)
- Estonia (until 25 Feb 2024)
- Finland (until 25 Feb 2024)
- France (until 25 Feb 2024)
- Germany (until 25 Feb 2024)
- Greece (until 25 Feb 2024)
- Hungary (until 25 Feb 2024)
- Iceland (until 25 Feb 2024)
- Ireland (until 25 Feb 2024)
- Italy (until 25 Feb 2024)
- Latvia (until 25 Feb 2024)
- Liechtenstein (until 25 Feb 2024)
- Lithuania (until 25 Feb 2024)
- Luxembourg (until 25 Feb 2024)
- Malta (until 25 Feb 2024)
- Netherlands (until 25 Feb 2024)
- Northern Ireland (until 25 Feb 2024)
- Norway (until 25 Feb 2024)
- Poland (until 25 Feb 2024)
- Portugal (until 25 Feb 2024)
- Romania (until 25 Feb 2024)
- Slovakia (until 25 Feb 2024)
- Slovenia (until 25 Feb 2024)
- Spain (until 25 Feb 2024)
- Sweden (until 25 Feb 2024)
- Türkiye (until 25 Feb 2024)
Specification
- Model / Reference
- 302.1, PDZ336
- Primary DI / UDI-DI
- 10887714014434
- Basic UDI-DI
- B-10887714014434
- EMDN Code
- C019014 Cardiac valvuloplasty catheters
- Device Class
- Class III
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000010948
- Authorised representative
- EVOMED S.L.U. ES-AR-000047116
Other devices from NuMED, Inc.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No