Ultrasonic Scalpel Generator
by Beneeon (Jiangsu) Medical Technology Co., Ltd.
Ref BN-CSD-100
Active
CE MDR
Valid until
2 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000305399 | Date25 Jun 2026 | StatusActive |
Certificates
- 1000305399 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 25 Jun 2026
- Expires
- 2 Mar 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ultrasonic Scalpel Generator
- Model / Reference
- BN-CSD-100
- Primary DI / UDI-DI
- 06972265907131
- Basic UDI-DI
- 69419986BNCSDS2J
- Direct Marketing DI
- 06972265907131
- EMDN Code
- Z12010801 Ultrasonic scalpel
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000035684
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (13)
- Sterile: No
- 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