Disposable Sterilized Laparoscopic Surgical Instruments Camera Drape
by Dongguan Senmed Medical Instrument Co., Ltd. EUDAMED
Active
Ref HC101220Model ACS-0001-000, ACS-0005-000, ACS-0012-000, ACS-0017-000, ACS-0039-000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN24/00006623 | Date12 Dec 2025 | 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- Withdrawn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 Camera Drape
- Model / Reference
- ACS-0001-000, ACS-0005-000, ACS-0012-000, ACS-0017-000, ACS-0039-000, HC101220
- Primary DI / UDI-DI
- 06975833140275
- Basic UDI-DI
- 697583314CD00058Z
- EMDN Code
- A03040299 Irrigation kits, single-use - other
- 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