ENDO REACH AFT Reload Units
by Reach Surgical, Inc. 10 variants
Ref ENDO AFT45PLBRModel ENDO AFT45TNR, ENDO AFT45PLR, ENDO AFT45BKR, ENDO AFT60TNR, ENDO AFT60PLR, ENDO AFT60BKR, ENDO AFT45TNBR, ENDO AFT60TNBR, ENDO AFT45PLBR, ENDO AFT60PLBR,
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 | Number69538158H442QW 06953815842782 | Date3 Jan 2024 | 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- Withdrawn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
- Single Use Loading Units for Endoscopic Linear Cutting Staplers
- Model / Reference
- ENDO AFT45TNR, ENDO AFT45PLR, ENDO AFT45BKR, ENDO AFT60TNR, ENDO AFT60PLR, ENDO AFT60BKR, ENDO AFT45TNBR, ENDO AFT60TNBR, ENDO AFT45PLBR, ENDO AFT60PLBR,
- Primary DI / UDI-DI
- 06953815842782
- Basic UDI-DI
- 69538158H442QW
- EMDN Code
- H02030199 Linear staplers for videosurgery - other
- Device Class
- Class IIb
- 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 (11)
- 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