Flexision Biopsy Needle, 19G
Ref 490204
Flexision Biopsy Needle, 19G (490204) is a Class IIa device made by Intuitive Surgical, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08868741230277X), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08868741230277X 00886874123805 | Date5 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 08868741230277X
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Ion Biopsy Needle
- Model / reference
- 490204
- Primary DI / UDI-DI
- 00886874123805
- Basic UDI-DI
- 08868741230277X
- EMDN code
- A010299 Biopsy needles and kits - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000020711
- Authorised representative
- Intuitive Surgical SAS FR-AR-000009053
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