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EcoFit® coupled impactor 30390115

by implantcast GmbH EUDAMEDGUDID

Active European Union

Ref 30390115Model ECOST10CIINST

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844ECOST10CIINSTZG Basic UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844242299 UDI-DIDate13 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
EcoFit® EUDAMED
EcoFit® coupled impactor GUDID
Generic Name
Orthopaedic implant impactor, reusable
Model / Reference
30390115, ECOST10CIINST
Primary DI / UDI-DI
04048844242299
Basic UDI-DI
4048844ECOST10CIINSTZG
Direct Marketing DI
04048844242299
FDA Product Code
HWA
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Reusable
  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No