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Inion Universal instruments

by Inion Oy 21 variants

Ref INS-9119

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

CE MDR CE MDD

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 NumberB-06438408003059 Basic UDI-DI 06438408003059UDI-DIDate30 Dec 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06438408003059 Basic UDI-DI 06438408003059UDI-DIDate30 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06438408003059 UDI-DI Date8 May 2020ListedStatusListed 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  • Withdrawn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, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical depth gauge, reusable
Device Name
Inion Universal instrument
Inion Instruments
Model / Ref / Catalog
INS-9119, 1
Primary DI / UDI-DI
06438408003059
Basic UDI-DI
B-06438408003059, 6438408INION-IRM-INSTRUAF
Secondary DI
M224INS91199
Direct Marketing DI
06438408003059
FDA Product Code
HTJ
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN Term
Surgical depth gauge, reusable
Device Class
Class I
Regulation Number
888.4300
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
INS-9119
GUDID
1

Manufacturer details

EUDAMED SRN
FI-MF-000000646

Other devices from Inion, Ltd.

See all devices from Inion, Ltd. →

Properties

  • Reusable
  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No