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Python®

by Shanghai InnoMed Technologies Inc. Ltd. 15 variants

Ref 200401500-080

Active European Union

CE MDR

Valid until

7 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69532222CE01KK Basic UDI-DI 06953222233265UDI-DIDate27 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0015 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    8 Apr 2026
    Expires
    7 Apr 2031

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 32 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 20 May 2026
  • Belgium since 20 May 2026
  • Bulgaria since 20 May 2026
  • Croatia since 20 May 2026
  • Cyprus since 20 May 2026
  • Czechia since 20 May 2026
  • Denmark since 20 May 2026
  • Estonia since 20 May 2026
  • Finland since 20 May 2026
  • France since 20 May 2026
  • Germany since 20 May 2026
  • Greece since 20 May 2026
  • Hungary since 20 May 2026
  • Iceland since 20 May 2026
  • Ireland since 20 May 2026
  • Italy since 20 May 2026
  • Latvia since 20 May 2026
  • Liechtenstein since 20 May 2026
  • Lithuania since 20 May 2026
  • Luxembourg since 20 May 2026
  • Malta since 20 May 2026
  • Netherlands since 20 May 2026
  • Northern Ireland since 20 May 2026
  • Norway since 20 May 2026
  • Poland since 20 May 2026
  • Portugal since 20 May 2026
  • Romania since 20 May 2026
  • Slovakia since 20 May 2026
  • Slovenia since 20 May 2026
  • Spain since 20 May 2026
  • Sweden since 20 May 2026
  • Türkiye since 20 May 2026

Last checked 2 Nov 2026.

Specification

EUDAMED

Device Name
Python® Drug-Eluting Balloon Dilatation Catheter
Model / Reference
200401500-080
Primary DI / UDI-DI
06953222233265
Basic UDI-DI
69532222CE01KK
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000039525
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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See all devices from Shanghai InnoMed Technologies Inc. Ltd. →

Properties

  • Sterile
  • Administering Medicine
  • Incorporates Medicinal Product

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No