Expect™
by Boston Scientific Corporation United States EUDAMEDGUDID
Ref M00559250 Product code FCGEMDN A010207
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01915060000000000000118MQ | Date31 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08714729861461 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Expect™ EUDAMEDExpect Pulmonary GUDID
- Generic Name
- Body aspiration needle, single-use
- Device Name
- Ebus-Tban
- Model / Reference
- M00559250
- Primary DI / UDI-DI
- 08714729861461
- Basic UDI-DI
- 01915060000000000000118MQ
- FDA Product Code
- FCG, EOQ
- EMDN Code
- A010207 Pulmonary biopsy needles and kits
- GMDN Term
- Body aspiration needle, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.1075, 874.4680
- 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
- Contains Latex: No
- Reprocessed: 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 4ae9880c-b91a-4f95-a9eb-21c49efe3774
- FDA UDI d3c9ea54-e508-4898-bab4-5bebde6d2f7c