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TruClear 7209509

by Covidien LP

Ref 7209509

TruClear 7209509 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 0763000B00005707U) and listed in FDA GUDID since 16 Oct 2017 (UDI-DI 10884521744103), active as of 24 Oct 2026.

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00005707U Basic UDI-DI 10884521744103UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521744103 UDI-DI Date16 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00005707U registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 10884521744103 listed 16 Oct 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884521744103
  2. Registered EUDAMED 0763000B00005707U

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  • Withdrawn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
TruClearTM EUDAMED
TruClear GUDID
Generic name
Tissue morcellation system
Device name
TruClear Tissue Removal Shaver
Model / reference
7209509
Primary DI / UDI-DI
10884521744103
Basic UDI-DI
0763000B00005707U
FDA product code
HIH
EMDN code
Z12020704 Hysteroscopes
GMDN term
Tissue morcellation system
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

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: Tissue morcellation system

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

Other devices from Covidien LP

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    Class II

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    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)