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Disposable Endoscopic Linear Cutter Stapler

EUDAMED

Class IIa (EU MDR)

Ref FH01Model FR SeriesModel FA Series

by Fengh Medical Co., Ltd.

Identity

Trade Name
Disposable Endoscopic Linear Cutter Stapler EUDAMED
Device Name
Disposable Endoscopic Linear Cutter Stapler EUDAMED
Model / Reference
FR Series EUDAMED
FH01 EUDAMED
FA Series EUDAMED

Identifiers

Primary DI / UDI-DI
06921348306712 EUDAMED
06921348306651 EUDAMED
06921348306644 EUDAMED
06921348306705 EUDAMED
Basic UDI-DI
69213483FH0101E4L EUDAMED
69213483FH0103E4S EUDAMED
69213483FH0103R5L EUDAMED
69213483FH0101R5E EUDAMED
EMDN Code
H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable Endoscopic Linear Cutter Stapler by Fengh Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Fengh Medical Co., Ltd.
EUDAMED SRN
CN-MF-000004718
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (4)

  • EUDAMED b4d3d00b-2857-4a8c-82e0-f3bbac38ecbb 61 fields · synced Sep 18, 2026
  • EUDAMED f43258fd-a790-45f9-952f-9ac65577aad2 61 fields · synced May 17, 2026
  • EUDAMED 51667cd5-2253-4d8e-8635-f68703ea8619 61 fields · synced May 17, 2026
  • EUDAMED 767ea246-ad08-4842-84ff-d122c3bd3fac 61 fields · synced May 19, 2026