Laparoscope
by Hunan Endoso Life Technology Co., Ltd United States EUDAMED
Ref 4KA45R1Model 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R1
EMDN Z12029009
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697520277004J5 | Date15 Dec 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R1, 4KA45R1
- Primary DI / UDI-DI
- 06975202770461
- Basic UDI-DI
- 697520277004J5
- EMDN Code
- Z12029009 Laparoscopes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000021400
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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
Sources (1)
- EUDAMED e459e4c9-75cf-4072-b713-d4c6a3691a9f