Skip to content

K01010101

by Fengh Medical Co., Ltd.

Ref FH07Model FSTC5,FLTC5,FXTC5,FSTC8,FLTC8,FXTC8,FSTC10,FLTC10,FXTC10,FSTC11,FLTC11,FXTC11,FSTC12,FLTC12,FXTC12,FSTC15,FLTC15,FXTC15

K01010101 (FH07) is a Class IIa device made by Fengh Medical Co., Ltd., registered in EUDAMED on 7 Sep 2022 (Basic UDI-DI 69213483FH0703E64), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69213483FH0703E64 Basic UDI-DI Date7 Sep 2022RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Disposable Endoscopic Trocar
Model / reference
FSTC5, FLTC5, FXTC5, FSTC8, FLTC8, FXTC8, FSTC10, FLTC10, FXTC10, FSTC11, FLTC11, FXTC11, FSTC12, FLTC12, FXTC12, FSTC15, FLTC15, FXTC15, FH07
Primary DI / UDI-DI
06921348304251, 06921348304190
Basic UDI-DI
69213483FH0703E64
EMDN code
K01010101 Trocar standard, single-use
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000004718
Authorised representative
Wellkang Ltd XI-AR-000001836

Similar devices in this category

Other devices filed under TROCAR STANDARD, SINGLE-USE.

Other devices from Fengh Medical Co., Ltd.

See all devices from Fengh Medical Co., Ltd. →

Properties

  • Supplied sterile
Other properties (13, all answered No)