Prosthetic Parts
by Future Technology Co., Ltd China EUDAMED
Ref 4R19Model 12HZ4,12HZ50,12HZ51,12HZ56,12HZ60,12P1,12P4,12P5,13R11,14HE20,15DH,15DP,15EA,15FA,15WJA,16DL,16SL,17BLH,17H100,17H300,17PK,18BLH,1E20 ,1E25,1EC21,1FC1,1FC10,1FC2,1FC25,1FC40,1FC45,1FC55,1FC60,1FC65,1FC70,1FM,1FO1,1FO2,1FS,etc
EMDN P09010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697922389PP001PH | Date24 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Prosthetic Parts
- Model / Reference
- 12HZ4, 12HZ50, 12HZ51, 12HZ56, 12HZ60, 12P1, 12P4, 12P5, 13R11, 14HE20, 15DH, 15DP, 15EA, 15FA, 15WJA, 16DL, 16SL, 17BLH, 17H100, 17H300, 17PK, 18BLH, 1E20, 1E25, 1EC21, 1FC1, 1FC10, 1FC2, 1FC25, 1FC40, 1FC45, 1FC55, 1FC60, 1FC65, 1FC70, 1FM, 1FO1, 1FO2, 1FS, etc, 4R19
- Primary DI / UDI-DI
- 06979223892638
- Basic UDI-DI
- 697922389PP001PH
- EMDN Code
- P09010301 Metal back and metaglene glenoid baseplates
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000049991
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Future Technology 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 6d29e838-6b2c-4432-830d-d5f91d5ab63f