Identity
- Trade Name
- FirefighterTM NC EUDAMED
- Device Name
- Firefighter NC PTCA Balloon Catheters EUDAMED
- Model / Reference
- FNC3510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939963810613 EUDAMED
- Basic UDI-DI
- B-06939963810613 EUDAMED
- EMDN Code
- C010401020101,C010401020102 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
No
EUDAMED
FirefighterTM NC by Shanghai MicroPort Medical (Group) Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06939963810613 | 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 a22eabdc-9766-49ae-884a-35bda4fe4f94 61 fields · synced May 23, 2026