Tri-Staple 2.0 SIGCIR25XT
by Covidien LP
Ref SIGCIR25XT
Tri-Staple 2.0 SIGCIR25XT is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0763000B00005457V) and listed in FDA GUDID since 31 Jul 2026 (UDI-DI 10884521703810), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0763000B00005457V 10884521703810 | Date4 Nov 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10884521703810 | Date31 Jul 2026 | StatusListed |
Official records
- EUDAMED public site 0763000B00005457V
- AccessGUDID record 10884521703810
Across registries
- EUDAMED Basic UDI-DI 0763000B00005457V registered 4 Nov 2026 Active
- FDA GUDID UDI-DI 10884521703810 listed 31 Jul 2026 Listed
Timeline
- Listed FDA GUDID 10884521703810
- Registered EUDAMED 0763000B00005457V
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Signia™ EUDAMEDTri-Staple 2.0 GUDID
- Generic name
- Surgical staple loading unit, cutting
- Device name
- Tri-Staple 2.0 Circular Reload
- Model / reference
- SIGCIR25XT
- Primary DI / UDI-DI
- 10884521703810
- Basic UDI-DI
- 0763000B00005457V
- FDA product code
- GDW, GAG
- EMDN code
- H02030299 Circular staplers for videosurgery – other
- GMDN term
- Surgical staple loading unit, cutting
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 878.4750, 878.4740
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Outer Diameter — 25 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |