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VesPenetrator®

by Dongguan TT Medical, Inc. 75 variants

Part of a family of 75 devices: see the family page

Ref 2SD07538Model VesPenetrator Balloon Catheter Series

VesPenetrator® (2SD07538) is a Class III device made by Dongguan Tt Medical, Inc., registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 069341840PDT6) with CE/MDR certificate MDR.2292-2026/0005 valid until 10 Feb 2031, active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

10 Feb 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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2026/0005 Date30 Sep 2026IssuedStatusActive expires 10 Feb 2031

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0005 Active Supplemented

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    30 Sep 2026
    Expires
    10 Feb 2031
    Reason
    Add device or group

Timeline

3 dated events

  1. Registered EUDAMED 069341840PDT6
  2. Certificate issued EUDAMED MDR.2292-2026/0005
  3. Certificate expires EUDAMED MDR.2292-2026/0005

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
VesPenetrator® Coronary Dilatation Balloon Catheters
Model / reference
VesPenetrator Balloon Catheter Series, 2SD07538
Primary DI / UDI-DI
06934184036460
Basic UDI-DI
069341840PDT6
EMDN code
C010401020101 Ptca balloon dilation catheters
Device class
Class III
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000039087
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under PTCA BALLOON DILATION CATHETERS.

Other devices from Dongguan Tt Medical, Inc.

  • Anchor™

    Class III

  • VesTrek™

    Class III

  • VesPenetrator®

    Class III

  • VexPander®

    Class III

See all devices from Dongguan Tt Medical, Inc. →

Properties

  • Supplied sterile
Other properties (13, all answered No)