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TruClear 72203004

by Covidien LP

Ref 72203004

TruClear 72203004 is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 0763000B000059286), cleared under FDA 510(k) K121904 on 11 Mar 2013 and listed in FDA GUDID since 11 Oct 2017 (UDI-DI 10884521744158), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121904

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000059286 Basic UDI-DI 10884521744158UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521744158 UDI-DI Date11 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121904 Date11 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000059286 registered 15 Jul 2026 Active
  • FDA 510(k) K121904 decided 11 Mar 2013 Active
  • FDA GUDID UDI-DI 10884521744158 listed 11 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121904
  2. Listed FDA GUDID 10884521744158
  3. Registered EUDAMED 0763000B000059286

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TruClearTM EUDAMED
TruClear GUDID
Generic name
Instrument tray, reusable
Device name
Gynecology Instrument Tray
Model / reference
72203004
Primary DI / UDI-DI
10884521744158
Basic UDI-DI
0763000B000059286
510(k) Number
FDA product code
KCT
EMDN code
Z12020704 Hysteroscopes
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10884521744158: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K121904)

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)