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Sjm™ 3875

by St. Jude Medical, Inc.

Part of a family of 9 devices: see the family page

Ref 3875

Sjm™ 3875 is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 5415067APP0001ES) with CE/MDR certificate MDR 725782 valid until 25 Jan 2031 and listed in FDA GUDID since 20 Nov 2015 (UDI-DI 05415067023681), active as of 24 Oct 2026.

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

CE MDR

Valid until

25 Jan 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067APP0001ES Basic UDI-DI 05415067023681UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067023681 UDI-DI Date20 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5415067APP0001ES registered 17 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067023681 listed 20 Nov 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 725782 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    25 Jun 2026
    Expires
    25 Jan 2031
    Reason
    Other

Timeline

4 dated events

  1. Listed FDA GUDID 05415067023681
  2. Certificate issued EUDAMED MDR 725782
  3. Registered EUDAMED 5415067APP0001ES
  4. Certificate expires EUDAMED MDR 725782

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  • Withdrawn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
Sjm™
Generic name
Multiple active implantable device programmer
Device name
Artemis, ORCA, and OneApp Software Apps
Model / Ref / Catalog
3875
Primary DI / UDI-DI
05415067023681
Basic UDI-DI
5415067APP0001ES
FDA product code
LGW
EMDN code
J020792 Neurostimulators programmers - medical device software
GMDN term
Multiple active implantable device programmer
Device class
Class III
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Multiple active implantable device programmer

Similar devices

Also classified as Multiple active implantable device programmer.

Similar devices in this category

Other devices filed under NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)