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InstruSafe

by Summit Medical, LLC United States EUDAMED

Ref IN-2020-0681

EMDN V0402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number03856490146_INSTRUSAJP Basic UDI-DIDate27 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers
Model / Reference
IN-2020-0681
Primary DI / UDI-DI
00385640015738
Basic UDI-DI
03856490146_INSTRUSAJP
Direct Marketing DI
00385640015738
EMDN Code
V0402 Clinical use trays and bowls
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000026771
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 00385640015738|03856490146_INSTRUSAJP 61 fields · synced 23 Oct 2026