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Instrument Case K9-2025

by Katena Products, Inc.

Ref K9-2025Model Instrument Sterilizing Case

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

CE MDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08416681K09X002A6A Basic UDI-DI 00841668110973UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841668110973 UDI-DI Date14 Sep 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
KATENA - Instrument Sterilizing Case EUDAMED
Instrument Case GUDID
Generic name
Instrument tray, reusable
Model / Ref / Catalog
K9-2025, Instrument Sterilizing Case
Primary DI / UDI-DI
00841668110973
Basic UDI-DI
08416681K09X002A6A
FDA product code
FSM
EMDN code
S010399 Materials for packaging packs to be sterilized - other
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Height — 25 Millimeter
Width — 110 Millimeter
Length — 200 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Supplied sterileEUDAMED
Yes
GUDID
No

Related devices

Category: Instrument tray, reusable

Other devices from Katena Products, Inc.

See all devices from Katena Products, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Premarket exempt

Other properties (21)

  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No