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Simplee

by Sterilance Medical (Suzhou) Inc. United States EUDAMED

Ref 156 623

EMDN V010101

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Disposable Scalpels
Model / Reference
156 623
Primary DI / UDI-DI
16945630144285
Basic UDI-DI
6945630107BM
Unit of Use DI
06945630144288
EMDN Code
V010101 Scalpels with safety systems, single-use
Device Class
Class IIa
Market of Registration
Sweden

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 16945630144285|6945630107BM 61 fields · synced 24 Oct 2026