swiftPAC Coil, 15 cm
by Penumbra, Inc. EUDAMED
Active
Ref 400SWPC15Model Embolization Coils
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 739883 | Date22 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- MDR 739883 Active
Technical documentation EU MDR
- Notified body
- BSI Group The Netherlands B.V. 2797
- Issued
- 22 Jun 2026
- Expires
- 28 Mar 2028
- Reason
- Other
Specification
- Device Name
- Penumbra Embolization Coil System
- Model / Reference
- Embolization Coils, 400SWPC15
- Primary DI / UDI-DI
- 00810169721483
- Basic UDI-DI
- 081454801PCOEU
- EMDN Code
- C010402020301 Embolisation coils
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000008514
- Authorised representative
- Penumbra Europe GmbH DE-AR-000004997
Other devices from Penumbra, Inc.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No