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FirehawkTM Rapamycin Target Eluting Coronary Stent System
EUDAMEDClass III (EU MDR)
Ref RV3018
Identity
- Trade Name
- FirehawkTM Rapamycin Target Eluting Coronary Stent System EUDAMED
- Device Name
- FirehawkTM Rapamycin Target Eluting Coronary Stent System EUDAMED
- Model / Reference
- RV3018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939963808856 EUDAMED
- Basic UDI-DI
- B-06939963808856 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
FirehawkTM Rapamycin Target Eluting Coronary Stent System by Shanghai MicroPort Medical (Group) Co., Ltd. — Class III — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06939963808856 | Class III | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort Medical (Group) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001110
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED ea745858-8a14-4638-94bb-8d13c6c49858 61 fields · synced Jun 19, 2026