IREACH OMNIA Staplers
by Reach Surgical, Inc. 6 variants
Ref IDLModel IDL, IDM, IDS
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69538158W014S 06953815846254 | Date2 Dec 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Powered Articulating Staplers
- Model / Reference
- IDL, IDM, IDS
- Primary DI / UDI-DI
- 06953815846254
- Basic UDI-DI
- 69538158W014S
- EMDN Code
- H02030199 Linear staplers for videosurgery - other
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011148
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Reach Surgical, Inc.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: 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