Extractor™
by Boston Scientific Corporation 18 variants
Ref M00547120
Active
CE MDR
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/MDR EUDAMED | Number01915060000000000000239N5 08714729790648 | Date31 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08714729790648 | 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- Withdrawn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
- Extractor™ EUDAMEDExtractor™ Pro XL GUDID
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval
- Model / Reference
- M00547120
- Primary DI / UDI-DI
- 08714729790648
- Basic UDI-DI
- 01915060000000000000239N5
- FDA Product Code
- FGE
- EMDN Code
- G03050101 Digestive endoscopy, retrieval balloon devices
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.5010
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004702
- Authorised representative
- Boston Scientific Limited IE-AR-000003840
Other devices from Boston Scientific
Properties
Other properties (18)
- Implantable: No
- Reusable: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No