IREACH MAGNUM PLUS Staplers
by Reach Surgical, Inc. 12 variants
Ref IMS45MModel IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S.
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 | Number69538158U004E 06953815846995 | Date29 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- Withdrawn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
- Endoscopic Motorized Cutting Staplers
- Model / Reference
- IM60AL, IM45AL, IM60AS, IM45AS, IM60AM, IM45AM, IMS60L, IMS60M, IMS60S, IMS45L, IMS45M, IMS45S.
- Primary DI / UDI-DI
- 06953815846995
- Basic UDI-DI
- 69538158U004E
- EMDN Code
- H02030199 Linear staplers for videosurgery - other
- Device Class
- Class IIa
- EU market of registration
- Spain
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