Abro
by Seawon Meditech Co., Ltd. 10 variants
Ref SWF31VP35F
Active
CE MDD
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/MDD | NumberB-08809272563211 08809272563211 | Date10 Apr 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- ABRO & Turtle Gun
- Model / Reference
- SWF31VP35F
- Primary DI / UDI-DI
- 08809272563211
- Basic UDI-DI
- B-08809272563211
- EMDN Code
- K0201010301 Open electrosurgery electrodes, single-use
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000007442
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Seawon Meditech Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No