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FirefighterTM

by Shanghai MicroPort Medical (Group) Co., Ltd. 20 variants

Ref RF4020, FNC2210, RF2710, RF2206, RF3515, FNC3720, FNC2706, FNC3515, FNC2215, FNC3006, RF1215, RF3710, FNC3015, FNC3520, FNC2520, RF3720, FNC4015, FNC2715, RF3215, RF3015, FNC4520, RF3220, RF3010, FNC2710, RF1520, FNC3020, RF1010, RF1015, RF1206, RF2020

Active European Union

CE MDR CE MDD

Valid until

9 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06939963810422 Basic UDI-DI Date24 May 2023RegisteredStatusActive
European UnionCE/MDD NumberB-06939963810422 Basic UDI-DI Date24 May 2023RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
FirefighterTM
FirefighterTM NC
Firefighter
Device Name
Firefighter PTCA Balloon Catheters
Firefighter NC PTCA Balloon Catheters
Firefighter PTCA Ballnoon Catheter
Model / Reference
RF4020, FNC2210, RF2710, RF2206, RF3515, FNC3720, FNC2706, FNC3515, FNC2215, FNC3006, RF1215, RF3710, FNC3015, FNC3520, FNC2520, RF3720, FNC4015, FNC2715, RF3215, RF3015, FNC4520, RF3220, RF3010, FNC2710, RF1520, FNC3020, RF1010, RF1015, RF1206, RF2020
Primary DI / UDI-DI
06939963810422, 06939963810446, 06939963810255, 06939963810163, 06939963810354, 06939963810668, 06939963810507, 06939963810620, 06939963810453, 06939963810545, 06939963810064, 06939963810378, 06939963810569, 06939963810637, 06939963810491, 06939963810392, 06939963810682, 06939963810521, 06939963810323, 06939963810293, 06939963810729, 06939963810330, 06939963810286, 06939963810514, 06939963810118, 06939963810576, 06939963810019, 06939963810026, 06939963810040, 06939963810156, 06942180398437, 06942180398673, 06942180398482, 06942180398475, 06942180398383, 06942180398611, 06942180398604, 06942180398741, 06942180398369, 06942180398697, 06942180398659, 06942180398345
Basic UDI-DI
B-06939963810422, B-06939963810446, B-06939963810255, B-06939963810163, B-06939963810354, B-06939963810668, B-06939963810507, B-06939963810620, B-06939963810453, B-06939963810545, B-06939963810064, B-06939963810378, B-06939963810569, B-06939963810637, B-06939963810491, B-06939963810392, B-06939963810682, B-06939963810521, B-06939963810323, B-06939963810293, B-06939963810729, B-06939963810330, B-06939963810286, B-06939963810514, B-06939963810118, B-06939963810576, B-06939963810019, B-06939963810026, B-06939963810040, B-06939963810156, 69421803C0B09AY
EMDN Code
C010401020101, C010401020102
Device Class
Class III
EU market of registration
Italy
France
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001110
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

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See all devices from Shanghai MicroPort Medical (Group) Co., Ltd. →

Properties

  • Sterile

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