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Inion CPS/OTPS instrumentation

by Inion Oy 20 variants

Ref INS-9001

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-06438408000249 Basic UDI-DI 06438408000249UDI-DIDate21 Dec 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06438408000249 Basic UDI-DI 06438408000249UDI-DIDate21 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06438408000249 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  • Withdrawn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
Fluted surgical drill bit, reusable
Device Name
Inion Instruments
Model / Ref / Catalog
INS-9001, 1
Primary DI / UDI-DI
06438408000249
Basic UDI-DI
B-06438408000249, 6438408INION-IIA-INSTRUUR
Secondary DI
M224INS900110
Direct Marketing DI
06438408000249
FDA Product Code
HTW
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
INS-9001
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
FI-MF-000000646

Other devices from Inion, Ltd.

See all devices from Inion, Ltd. →

Properties

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

Other properties (19)

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