Disposable Sterilized Laparoscopic Surgical Instruments Sharps Holder
by Dongguan Senmed Medical Instrument Co., Ltd. EUDAMED
Active
Ref NC30DMBRModel ASB-0001-000, ASB-0004-000, ASB-0006-000, ASB-0009-000, ASB-0010-000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697583314SMB0004RX | Date19 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN24/00006623 Supplemented
Quality assurance EU MDR
- Notified body
- Notified body 1639
- Issued
- 12 Dec 2025
- Expires
- 18 Oct 2029
- Reason
- Change approved
Specification
- Device Name
- Disposable Sterilized Laparoscopic Surgical Instruments Sharps Holder
- Model / Reference
- ASB-0001-000, ASB-0004-000, ASB-0006-000, ASB-0009-000, ASB-0010-000, NC30DMBR
- Primary DI / UDI-DI
- 06975833143191
- Basic UDI-DI
- 697583314SMB0004RX
- EMDN Code
- V9012 Non-specialist surgical instruments and kits, single-use
- Device Class
- Class I
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000028972
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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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