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LacriCATH DCP213-BIT

by Quest Medical Inc

Ref DCP213-BIT

LacriCATH DCP213-BIT is a device classified as Class IIa (EU), Unclassified (US) made by Quest Medical Inc, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-20634624438228), cleared under FDA 510(k) K113867 on 19 Oct 2012 and listed in FDA GUDID since 18 May 2016 (UDI-DI 20634624438228), active as of 25 Oct 2026.

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

CE MDD 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) K113867

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/MDD EUDAMED NumberB-20634624438228 Basic UDI-DI 20634624438228UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20634624438228 UDI-DI Date18 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113867 Date19 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20634624438228 registered 22 Sep 2026 Active
  • FDA 510(k) K113867 decided 19 Oct 2012 Active
  • FDA GUDID UDI-DI 20634624438228 listed 18 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113867
  2. Listed FDA GUDID 20634624438228
  3. Registered EUDAMED B-20634624438228

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
LacriCath® DCP 2mm Bilateral Procedure Kit EUDAMED
LacriCATH GUDID
Generic name
Lacrimal intubation set
Model / reference
DCP213-BIT
Primary DI / UDI-DI
20634624438228
Basic UDI-DI
B-20634624438228
510(k) Number
FDA product code
OKS
EMDN code
Q021113 Ophthalmic surgery instrument kits, single-use
GMDN term
Lacrimal intubation set
Device class
Class IIa EUDAMED
U GUDID
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
U

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

Related devices

Category: Lacrimal intubation set

Cleared under the same submission (K113867)

and 4 more cleared under K113867

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE.

Other devices from Quest Medical Inc

See all devices from Quest Medical Inc →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)