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THD Bandy

by Thd SpA

THD Bandy (800079) is a Class II device made by Thd SpA, cleared under FDA 510(k) K093497 on 15 Jul 2010, registered in EUDAMED and listed in FDA GUDID since 7 Oct 2016 (UDI-DI 08033737710685), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093497↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08033737710685 UDI-DI Date7 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK093497 Date15 Jul 2010IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K093497 decided 15 Jul 2010 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08033737710685 listed 7 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K093497
  2. Listed FDA GUDID 08033737710685

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Haemorrhoid ligation set
Model / Ref / Catalog
THD Bandy, 800079
Primary DI / UDI-DI
08033737710685
510(k) Number
FDA product code
FHN
GMDN term
Haemorrhoid ligation set
Device class
Class II
Regulation number
876.4400
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 12.8 Millimeter
Length — 154 Millimeter

Related devices

Category: Haemorrhoid ligation set

Similar devices

Other devices filed under FDA product code FHN (Ligator, Hemorrhoidal).

Other devices from Thd SpA

See all devices from Thd SpA →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)