Disposable electrosurgical pencil
by Zhejiang Haisheng Medical Device Co., Ltd. 46 variants
Ref HEP12
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-06944375391544 06944375391544 | Date19 May 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- Withdrawn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
- Model / Reference
- HEP12
- Primary DI / UDI-DI
- 06944375391544
- Basic UDI-DI
- B-06944375391544
- EMDN Code
- K0201010301 Open electrosurgery electrodes, single-use
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000026345
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Zhejiang Haisheng Medical Device Co., Ltd.
See all devices from Zhejiang Haisheng Medical Device 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