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Ethicon EC3D60L

by Ethicon Endo-Surgery, LLC

Ref EC3D60LModel ETHICON 4000 Stapler

Ethicon EC3D60L is a device classified as Class III in the EU and Class II in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI 0705036a002917D) with CE/MDR certificate G70 057666 0084 valid until 1 Dec 2030 and listed in FDA GUDID since 22 Aug 2025 (UDI-DI 10705036043546), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Dec 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a002917D Basic UDI-DI 10705036043546UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705036043546 UDI-DI Date22 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705036a002917D registered 24 Jun 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705036043546 listed 22 Aug 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Listed FDA GUDID 10705036043546
  2. Certificate issued EUDAMED G70 057666 0084
  3. Registered EUDAMED 0705036a002917D
  4. Certificate expires EUDAMED G70 057666 0084

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  • Withdrawn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
Ethicon
Generic name
Endoscopic motorized cutting stapler, single-use
Device name
ETHICON 4000 Stapler
Model / Ref / Catalog
EC3D60L, ETHICON 4000 Stapler
Primary DI / UDI-DI
10705036043546
Basic UDI-DI
0705036a002917D
FDA product code
GAG
EMDN code
H020301050101, H020301050102
GMDN term
Endoscopic motorized cutting stapler, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4740
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Endoscopic motorized cutting stapler, single-use

Similar devices in this category

Other devices filed under SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEO SURGERY.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)