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Orthopediatrics® Instrumentation

by OrthoPediatrics Corp. United States EUDAMED

Ref 01-1010-009-SModel 01-1007-0028 EMDN P091303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08411321CIIADB3F Basic UDI-DIDate29 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
01-1007-0028, 01-1010-009-S
Primary DI / UDI-DI
00840194400831
Basic UDI-DI
08411321CIIADB3F
EMDN Code
P091303 Orthopaedic implant drill bits, single-use
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001776
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reusable
Other properties (11)
  • Implantable: 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 00840194400831|08411321CIIADB3F 61 fields · synced 25 Oct 2026