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FoxtrotTM NC

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

Ref PH2715, PH4006, PH4520, PH2706, PH4008, PH5020, PH4012, PH3020, PH2515, PH3506, PH3706, PH5008, PH2712, PH4015, PH3515, PH3512, PH3208, PH2720, PH2508, PH4010, PH2212, PH2520, PH3015, PH2506, PH3720, PH2220, PH2215, PH3206, PH4508, PH3220, PH3508, PH3712, PH2708, PH3010, PH4506, PH3510, PH2210

Active European Union

CE MDR CE MDD

Valid until

7 Oct 2031

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 115436 0006 Date8 Oct 2026IssuedStatusActive expires 7 Oct 2031
European UnionCE/MDD NumberB-06939963816059 Basic UDI-DI Date17 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  • Withdrawn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
FoxtrotTM NC
Foxtrot Nc
Device Name
Foxtrot NC PTCA Balloon Catheters
FOXTROT NC PTCA Balloon Catheter
Model / Reference
PH2715, PH4006, PH4520, PH2706, PH4008, PH5020, PH4012, PH3020, PH2515, PH3506, PH3706, PH5008, PH2712, PH4015, PH3515, PH3512, PH3208, PH2720, PH2508, PH4010, PH2212, PH2520, PH3015, PH2506, PH3720, PH2220, PH2215, PH3206, PH4508, PH3220, PH3508, PH3712, PH2708, PH3010, PH4506, PH3510, PH2210
Primary DI / UDI-DI
06939963816059, 06939963816318, 06939963816424, 06939963816011, 06939963816325, 06939963816486, 06939963816349, 06939963816127, 06939963815991, 06939963816196, 06939963816257, 06939963816448, 06939963816042, 06939963816356, 06939963816233, 06939963816226, 06939963816141, 06939963816066, 06939963815960, 06939963816332, 06939963815922, 06939963816004, 06939963816110, 06939963815953, 06939963816301, 06939963815946, 06939963815939, 06939963816134, 06939963816387, 06939963816189, 06939963816202, 06939963816288, 06939963816028, 06939963816097, 06939963816370, 06939963816219, 06939963815915, 06939963828212, 06939963828229, 06939963828557, 06939963828526, 06939963828519, 06939963828113, 06939963828366, 06939963828281, 06939963828083, 06939963828106, 06939963828397, 06939963828595, 06939963828403
Basic UDI-DI
B-06939963816059, B-06939963816318, B-06939963816424, B-06939963816011, B-06939963816325, B-06939963816486, B-06939963816349, B-06939963816127, B-06939963815991, B-06939963816196, B-06939963816257, B-06939963816448, B-06939963816042, B-06939963816356, B-06939963816233, B-06939963816226, B-06939963816141, B-06939963816066, B-06939963815960, B-06939963816332, B-06939963815922, B-06939963816004, B-06939963816110, B-06939963815953, B-06939963816301, B-06939963815946, B-06939963815939, B-06939963816134, B-06939963816387, B-06939963816189, B-06939963816202, B-06939963816288, B-06939963816028, B-06939963816097, B-06939963816370, B-06939963816219, B-06939963815915, 69399638Z0257WF
EMDN Code
C010401020101, C010401020102
Device Class
Class III
EU market of registration
Spain
Italy

Manufacturer details

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

Other devices from Shanghai Microport Medical (Group) Co., Ltd

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Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No