Tycheseal™
by Beijing Percutek Therapeutics Inc. China EUDAMED
Ref PTBS3628150Model PTBS
EMDN P070401010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06957485020853 | Date23 Jun 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
EU market availability
Available in 32 countries, as listed in EUDAMED:
- 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
Specification
- Device Name
- Tycheseal™ Thoracic stent graft system
- Model / Reference
- PTBS, PTBS3628150
- Primary DI / UDI-DI
- 06957485020853
- Basic UDI-DI
- B-06957485020853
- EMDN Code
- P070401010102 Dacron vascular endoprostheses, straight - thoracic
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000013927
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Beijing Percutek Therapeutics 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 ff932e53-f865-4498-8d39-d26648d2f731