Truselect™ M001394101050
Ref M001394101050
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01915060000000000000455ND 08714729976608 | Date14 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08714729976608 | Date17 Aug 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Truselect™
- Generic name
- Vascular microcatheter
- Device name
- Truselect
- Model / reference
- M001394101050
- Primary DI / UDI-DI
- 08714729976608
- Basic UDI-DI
- 01915060000000000000455ND
- FDA product code
- KRA
- EMDN code
- C0104020299 Peripheral angiography therapeutic devices - other
- GMDN term
- Vascular microcatheter
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 870.1210
- EU registration type
- Standard device
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Length — 105 CentimeterCatheter Inner Diameter — 0.53 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
Other devices from Boston Scientific
Properties
Other properties (18)
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No