Occluder™
by Boston Scientific Corporation United States EUDAMEDGUDID
Ref M0062201090
Product code EYBEMDN U020202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01915060000000000000267NA | Date1 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08714729192008 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Ureteropelvic balloon catheter
- Device Name
- Occluder Occlusion Balloon Catheter
- Model / Reference
- M0062201090
- Primary DI / UDI-DI
- 08714729192008
- Basic UDI-DI
- 01915060000000000000267NA
- FDA Product Code
- EYB
- EMDN Code
- U020202 Ureteral catheters with flute tip with balloon
- GMDN Term
- Ureteropelvic balloon catheter
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.5130
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004702
- Authorised representative
- Boston Scientific Limited IE-AR-000003840
Other devices from Boston Scientific
Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 78680134-2e5c-46eb-b74d-1d0a8e1bdb33
- FDA UDI 297f61eb-8478-4dfe-b22f-a55512c67b2a