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Emprint HP CARTHP

by Covidien LP

Ref CARTHP

Emprint HP CARTHP is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 0763000B00008568H), cleared under FDA 510(k) K200796 on 26 Aug 2020 and listed in FDA GUDID since 7 Nov 2020 (UDI-DI 10884521806443), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200796

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/MDR EUDAMED Number0763000B00008568H Basic UDI-DI 10884521806443UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521806443 UDI-DI Date7 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200796 Date26 Aug 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00008568H registered 16 Oct 2026 Active
  • FDA 510(k) K200796 decided 26 Aug 2020 Active
  • FDA GUDID UDI-DI 10884521806443 listed 7 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200796
  2. Listed FDA GUDID 10884521806443
  3. Registered EUDAMED 0763000B00008568H

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  • Withdrawn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
Emprint™ EUDAMED
Emprint HP GUDID
Generic name
Electromechanical device/system transport trolley
Device name
HP Ablation Cart
Model / reference
CARTHP
Primary DI / UDI-DI
10884521806443
Basic UDI-DI
0763000B00008568H
510(k) Number
FDA product code
NEY
EMDN code
L1899 Electrosurgery instruments, reusable - other
GMDN term
Electromechanical device/system transport trolley
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
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.

Related devices

Category: Electromechanical device/system transport trolley

Cleared under the same submission (K200796)

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Covidien LP

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)