Charger™ H74939206060410
Ref H74939206060410
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | Number01915060000000000000344N3 08714729804383 | Date14 Sep 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number01915060000000000000344N3 08714729804383 | Date14 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08714729804383 | Date24 Sep 2015 | 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- Withdrawn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
- Charger™
- Generic name
- Peripheral angioplasty balloon catheter, basic
- Device name
- Charger PTA Balloon Dilatation Catheter
- Model / Ref / Catalog
- H74939206060410
- Primary DI / UDI-DI
- 08714729804383
- Basic UDI-DI
- 01915060000000000000344N3, B-08714729804383
- FDA product code
- FGE, LIT
- EMDN code
- C010402020101 PTA balloon dilatation catheters
- GMDN term
- Peripheral angioplasty balloon catheter, basic
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 876.5010, 870.1250
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class II |
Other devices from Boston Scientific
Properties
Other properties (19)
- 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 endocrine-disrupting substances: No
- Administering medicine: 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
- Manufacturing date: No