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Catchem'

by Endo-Therapeutics Inc. 2 variants

Ref ET2213

Catchem' (ET2213) is a surgical suction system collection container (EU MDR Class I; FDA Class II; FDA product code KDQ, Bottle, Collection, Vacuum) made by Endo-Therapeutics Inc., registered in EUDAMED on 3 Aug 2023 (Basic UDI-DI 081620702polyptrapAK) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00816207020389), active as of 8 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081620702polyptrapAK Basic UDI-DI 00816207020389UDI-DIDate3 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816207020389 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081620702polyptrapAK registered 3 Aug 2023 Active
  • FDA GUDID UDI-DI 00816207020389 listed 22 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00816207020389
  2. Registered EUDAMED 081620702polyptrapAK

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  • Withdrawn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
Catchem' EUDAMED
Catchem' Polyp Trap GUDID
Generic name
Surgical suction system collection container, single-use
Device name
Polyp Trap
Model / Ref / Catalog
ET2213
Primary DI / UDI-DI
00816207020389
Basic UDI-DI
081620702polyptrapAK
FDA product code
KDQ
EMDN code
G0399 Digestive endoscopy devices - other
GMDN term
Surgical suction system collection container, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000002267
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - OTHER.

Other devices from Endo-Therapeutics Inc.

See all devices from Endo-Therapeutics Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)