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AMT Clamp™ E4-3000

by Applied Medical Technology, Inc.

Ref E4-3000

AMT Clamp™ E4-3000 is a device classified as Class I in the EU and Class II in the US made by Applied Medical Technology, Inc., registered in EUDAMED on 23 Jan 2026 (Basic UDI-DI 08420711CLAMPAA), cleared under FDA 510(k) K971757 on 7 Nov 1997 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00842071106874), active as of 7 Nov 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 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K971757

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08420711CLAMPAA Basic UDI-DI 00842071106874UDI-DIDate23 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071106874 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK971757 Date7 Nov 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08420711CLAMPAA registered 23 Jan 2026 Active
  • FDA 510(k) K971757 decided 7 Nov 1997 Active
  • FDA GUDID UDI-DI 00842071106874 listed 23 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K971757
  2. Listed FDA GUDID 00842071106874
  3. Registered EUDAMED 08420711CLAMPAA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AMT Clamp - Feeding Tube Connector EUDAMED
AMT Clamp™ GUDID
Generic name
Catheter/tubing connector securement clip
Device name
AMT Clamp
Model / Ref / Catalog
E4-3000, 4-3000
Primary DI / UDI-DI
00842071106874
Basic UDI-DI
08420711CLAMPAA
510(k) Number
FDA product code
KNT
EMDN code
G020299 Gastrointestinal feeding/aspiration tubes - other
GMDN term
Catheter/tubing connector securement clip
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5980
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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.

Related devices

Category: Catheter/tubing connector securement clip

Cleared under the same submission (K971757)

and 8 more cleared under K971757

Similar devices in this category

Other devices filed under GASTROINTESTINAL FEEDING/ASPIRATION TUBES.

Other devices from Applied Medical Technology, Inc.

See all devices from Applied Medical Technology, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)