Intervention Accessories Kit
by Shanghai INT Medical Instruments Co., Ltd. China EUDAMED
Ref KDL-YX-001Model KDL-YX-001~KDL-YX-020
EMDN C0601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-IAKCY | Date26 Mar 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Model / Reference
- KDL-YX-001~KDL-YX-020, KDL-YX-001
- Primary DI / UDI-DI
- D-IAKCY
- Basic UDI-DI
- B-IAKCY
- EMDN Code
- C0601 Cardiovascular surgery instrument kits not included in other classes, single-use
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009966
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 1d0db132-b764-4e90-b2c0-aa69b948c595