Skip to content

X-Cut

by Sterilance Medical (Suzhou) Inc. 14 variants

Ref 06945630147067

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6945630107BM Basic UDI-DI 16945630147064UDI-DIDate24 Feb 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable Scalpels
Model / Reference
06945630147067
Primary DI / UDI-DI
16945630147064
Basic UDI-DI
6945630107BM
Unit of Use DI
06945630147067
EMDN Code
V010101 Scalpels with safety systems, single-use
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000002860
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Sterilance Medical (Suzhou) Inc.

See all devices from Sterilance Medical (Suzhou) Inc. →

Properties

  • Sterile

Other properties (12)

  • 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