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EcoFit® 133° trial neck standard for broach 133° 70501214

by implantcast GmbH

Ref 70501214Model ECOST12NTINST

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844ECOST12NTINSTAV Basic UDI-DI 04048844310103UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844310103 UDI-DI Date27 Mar 2019ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
EcoFit® EUDAMED
EcoFit® 133° trial neck standard for broach 133° GUDID
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Reference
70501214, ECOST12NTINST
Primary DI / UDI-DI
04048844310103
Basic UDI-DI
4048844ECOST12NTINSTAV
Direct Marketing DI
04048844310103
FDA Product Code
LZO
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3353
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • CMR Substance
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No