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TruClear 72204753

by Covidien LP

Ref 72204753

TruClear 72204753 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 0763000B000250783), cleared under FDA 510(k) K152143 on 2 Sep 2015 and listed in FDA GUDID since 11 Jul 2020 (UDI-DI 10884521746756), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152143

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000250783 Basic UDI-DI 10884521746756UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521746756 UDI-DI Date11 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK152143 Date2 Sep 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000250783 registered 6 Jul 2026 Active
  • FDA 510(k) K152143 decided 2 Sep 2015 Active
  • FDA GUDID UDI-DI 10884521746756 listed 11 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152143
  2. Listed FDA GUDID 10884521746756
  3. Registered EUDAMED 0763000B000250783

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  • Withdrawn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
Rigid optical hysteroscope
Device name
TruClear Sheath 5C
Model / reference
72204753
Primary DI / UDI-DI
10884521746756
Basic UDI-DI
0763000B000250783
Direct marketing DI
10884521746756
510(k) Number
FDA product code
HIH
EMDN code
Z12020704 Hysteroscopes
GMDN term
Rigid optical hysteroscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.7 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Rigid optical hysteroscope

Cleared under the same submission (K152143)

and 1 more cleared under K152143

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)