Tycheseal™
by Beijing Percutek Therapeutics Inc. 510 variants
Ref PAIL1613095Model PAIL
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-06957485010298 06957485010298 | Date23 Jun 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- Withdrawn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
EU market availability
Made available in 32 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece since 7 Dec 2022
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Device Name
- Tycheseal™ Abdominal aortic stent graft system
- Model / Reference
- PAIL, PAIL1613095
- Primary DI / UDI-DI
- 06957485010298
- Basic UDI-DI
- B-06957485010298
- EMDN Code
- P0704010102 Dacron vascular endoprostheses, bifurcated
- Device Class
- Class III
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000013927
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Beijing Percutek Therapeutics Inc.
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