Skip to content

Prosthetic Parts

by Future Technology Co., Ltd China EUDAMED

Ref 1FC190Model 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

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697922389PP001PH Basic UDI-DIDate24 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

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, 1FC190
Primary DI / UDI-DI
06979223895134
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

See all 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 b75d0d8f-20f0-4162-a3da-24bf16cd5a9f 61 fields · synced 24 Oct 2026