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PULSTA ™ Transcatheter Pulmonary Valve System
EUDAMEDClass I (EU MDR)
Ref RSS18
Identity
- Trade Name
- PULSTA ™ Transcatheter Pulmonary Valve System EUDAMED
- Device Name
- Crimping Tool EUDAMED
- Model / Reference
- RSS18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809909406171 EUDAMED
- Basic UDI-DI
- 880990940RSSWN EUDAMED
- EMDN Code
- P07038002 CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PULSTA ™ Transcatheter Pulmonary Valve System by Taewoong Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880990940RSSWN | Class I | Active |
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Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000007515
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 2ceaae04-7600-40ba-b3d4-85cac05f7ca6 61 fields · synced Oct 7, 2026