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Heel Incision

by Sterilance Medical (Suzhou) Inc. United States EUDAMED

Ref SterilHeel Plus 0.65x1.4mm EMDN V010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6945630130BG Basic UDI-DIDate23 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Heel Incision
Model / Reference
SterilHeel Plus 0.65x1.4mm
Primary DI / UDI-DI
16945630118026
Basic UDI-DI
6945630130BG
Unit of Use DI
06945630118029
EMDN Code
V010401 Lancets with safety systems, single-use
Device Class
Class IIa
Market of Registration
Austria

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 16945630118026|6945630130BG 61 fields · synced 25 Oct 2026