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Disposable Endoscopic Stapler

by Wuxi Beien Surgery Device Co., Ltd. 6 variants

Ref ELS, ELS12-CModel ELS12-S,ELS15-S,ELS12-C,ELS15-C,ELS12-E,ELS15-E,ELSC-S,ELSC-C,ELSC-E,ELST-S,ELST-C,ELST-E,ELSJ-S,ELSJ-C,ELSJ-E

Disposable Endoscopic Stapler (ELS) is a Class IIa device made by Wuxi Beien Surgery Device Co., Ltd., registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 697176787ELSXB), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697176787ELSXB Basic UDI-DI 06971767871216UDI-DIDate8 Apr 2026RegisteredStatusActive
European UnionCE/MDR Number697176787ELSXB Basic UDI-DI 06971767871216UDI-DIDate8 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade name
Disposable Endoscopic Stapler
Disposable Endoscopic Staplers and Reload Unit
Device name
Disposable Endoscopic Staplers
Model / reference
ELS12-S, ELS15-S, ELS12-C, ELS15-C, ELS12-E, ELS15-E, ELSC-S, ELSC-C, ELSC-E, ELST-S, ELST-C, ELST-E, ELSJ-S, ELSJ-C, ELSJ-E, ELS
Primary DI / UDI-DI
06971767871216
Basic UDI-DI
697176787ELSXB, B-06971767871216
EMDN code
H020201010101, H020301040199
Device class
Class IIa
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Türkiye
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017684
Authorised representative
Prolinx GmbH DE-AR-000005129

Similar devices in this category

Other devices filed under SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY.

Other devices from Wuxi Beien Surgery Device Co., Ltd.

See all devices from Wuxi Beien Surgery Device Co., Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoEUDAMED
Other properties (12, all answered No)