Skip to content

ecoPass L

by S.B.M

Ref EPA9000454Model Automatic suture passer & associated needles

ecoPass L (EPA9000454) is a Class I device made by S.B.M, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 376015400DT2019035VN) and listed in FDA GUDID since 26 Jun 2025 (UDI-DI 03760304681615), active as of 23 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376015400DT2019035VN Basic UDI-DI 03760304681615UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760304681615 UDI-DI Date26 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376015400DT2019035VN registered 9 Jul 2026 Active
  • FDA GUDID UDI-DI 03760304681615 listed 26 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760304681615
  2. Registered EUDAMED 376015400DT2019035VN

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  • Withdrawn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

Generic name
Suturing unit, reusable
Device name
Automatic suture passer & associated needles
Model / Ref / Catalog
Automatic suture passer & associated needles, EPA9000454, Suture passer automatic grasper Large (Shoulder)
Primary DI / UDI-DI
03760304681615
Basic UDI-DI
376015400DT2019035VN
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Suturing unit, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Automatic suture passer & associated needles
EPA9000454
GUDID
Suture passer automatic grasper Large (Shoulder)

Related devices

Category: Suturing unit, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)