prosthetic parts
by Ge Rui Hong Kang Medical Technology(SanHe) Co., Ltd China EUDAMED
Ref CHL-03Model CHG-01,CHG-02,CHG-03,CHG-05,CHG-06,CHG-09,K09,K13AL,K15AL,K16AL,K17AL,K18AL,K19AL,K20AL,CHG-10,CHG-11,CHG-12,CHG-13 CHL-01,CHL-02S,CHL-03,CHL-04,CHL-05S,CHL-06,CHL-06A,CHL-07,CHL-07A,CHL-08,CHL-09,CHL-09A,CHL-10AS,CHL-10,CHL-11, etc
EMDN Y0699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697831171ProstheticZK | Date25 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- prosthetic parts
- Model / Reference
- CHG-01, CHG-02, CHG-03, CHG-05, CHG-06, CHG-09, K09, K13AL, K15AL, K16AL, K17AL, K18AL, K19AL, K20AL, CHG-10, CHG-11, CHG-12, CHG-13 CHL-01, CHL-02S, CHL-03, CHL-04, CHL-05S, CHL-06, CHL-06A, CHL-07, CHL-07A, CHL-08, CHL-09, CHL-09A, CHL-10AS, CHL-10, CHL-11, etc
- Primary DI / UDI-DI
- 06978311710205
- Basic UDI-DI
- 697831171ProstheticZK
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000046610
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ge Rui Hong Kang Medical Technology(SanHe) Co., Ltd
See all devices from Ge Rui Hong Kang Medical Technology(SanHe) Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 8d677cb0-aeb1-4a98-9be9-983542f64ed1