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Merlin™ 3650

by St. Jude Medical, Inc.

Ref 3650

Merlin™ 3650 is a device classified as Active implantable (AIMDD) (EU), Class III (US) made by St. Jude Medical, Inc., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI B-05414734500661) and listed in FDA GUDID since 30 Sep 2014 (UDI-DI 05414734500661), active as of 23 Oct 2026.

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

CE MDD CE AIMDD

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/AIMDD EUDAMED NumberB-05414734500661 Basic UDI-DI 05414734500661UDI-DIDate6 Jul 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-05414734500661 Basic UDI-DI 05414734500661UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734500661 UDI-DI Date30 Sep 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05414734500661 registered 6 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05414734500661 listed 30 Sep 2014 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05414734500661
  2. Registered EUDAMED B-05414734500661

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Merlin™
Generic name
Multiple active implantable device programmer
Device name
Merlin Programmer
Model / Ref / Catalog
3650
Primary DI / UDI-DI
05414734500661
Basic UDI-DI
B-05414734500661
FDA product code
NIK
EMDN code
J01900280 Implantable cardiac devices programmers - hardware accessory
GMDN term
Multiple active implantable device programmer
Device class
Class AIMDD EUDAMED
Class III GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class AIMDD
GUDID
Class III

Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under IMPLANTABLE CARDIAC DEVICES - VARIOUS.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)