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TruClear 7209807

by Covidien LP

Ref 7209807

TruClear 7209807 is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 0763000B00005978G) and listed in FDA GUDID since 10 Mar 2019 (UDI-DI 10884521749924), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00005978G Basic UDI-DI 10884521749924UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521749924 UDI-DI Date10 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00005978G registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 10884521749924 listed 10 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884521749924
  2. Registered EUDAMED 0763000B00005978G

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  • Withdrawn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™ Handpiece
Model / reference
7209807
Primary DI / UDI-DI
10884521749924
Basic UDI-DI
0763000B00005978G
Direct marketing DI
10884521749924
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
Sterilisation method
Moist Heat or Steam Sterilization

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.

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See all devices from Covidien LP →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)