VesPenetrator®
by Dongguan TT Medical, Inc. 75 variants
Part of a family of 75 devices: see the family page
Ref 2SD15034Model VesPenetrator Balloon Catheter Series
VesPenetrator® (2SD15034) 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 24 Oct 2026.
Active
CE MDR
Valid until
10 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR.2292-2026/0005 | Date30 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 069341840PDT6
Certificates
- MDR.2292-2026/0005 Active
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
- Registered EUDAMED 069341840PDT6
- Certificate issued EUDAMED MDR.2292-2026/0005
- Certificate expires EUDAMED MDR.2292-2026/0005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- VesPenetrator® Coronary Dilatation Balloon Catheters
- Model / reference
- VesPenetrator Balloon Catheter Series, 2SD15034
- Primary DI / UDI-DI
- 06934184012983
- 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
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