Anchor™
by Dongguan TT Medical, Inc. EUDAMED 378 variants
Active
Ref DST30015Model Anchor™ DST Balloon Catheter Series
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR.2292-2026/0005 | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
- MDR.2292-2026/0005 Active
Technical documentation EU MDR
- Notified body
- 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
Specification
- Device Name
- Anchor™ DST Coronary Dilatation Balloon Catheters
- Model / Reference
- Anchor™ DST Balloon Catheter Series, DST30015
- Primary DI / UDI-DI
- 06934184045912
- Basic UDI-DI
- 069341840DSTJC
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- Market of Registration
- Croatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000039087
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Dongguan Tt Medical, Inc.
Properties
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