Jetstream™
by Boston Scientific Corporation 8 variants
Ref 112260-003
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08714729889854 08714729889854 | Date4 Nov 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Jetstream SC 1.6mm (EU)
- Model / reference
- 112260-003
- Primary DI / UDI-DI
- 08714729889854
- Basic UDI-DI
- B-08714729889854
- EMDN code
- C010402020602 Peripheral atherectomy systems, rotational
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000004702
- Authorised representative
- Boston Scientific Limited IE-AR-000003840
Other devices from Boston Scientific
Properties
Other properties (13)
- 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
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No