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Medtronic 5944RL

by Shenzhen Launch Electrical Co., Ltd

Ref 5944RL

Medtronic 5944RL is a device classified as Class I in the EU and Class II in the US made by Shenzhen Launch Electrical Co., Ltd, registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 69474379CompassBP), cleared under FDA 510(k) K241199 on 23 Jan 2025 and listed in FDA GUDID since 8 Feb 2025 (UDI-DI 06947437902535), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241199

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69474379CompassBP Basic UDI-DI 06947437902535UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947437902535 UDI-DI Date8 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241199 Date23 Jan 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69474379CompassBP registered 7 Jul 2026 Active
  • FDA 510(k) K241199 decided 23 Jan 2025 Active
  • FDA GUDID UDI-DI 06947437902535 listed 8 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241199
  2. Listed FDA GUDID 06947437902535
  3. Registered EUDAMED 69474379CompassBP

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  • Withdrawn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
Rotatable connector EUDAMED
Medtronic GUDID
Generic name
Electrical-only medical device connection cable, single-use
Model / reference
5944RL
Primary DI / UDI-DI
06947437902535
Basic UDI-DI
69474379CompassBP
Direct marketing DI
06947437902535
510(k) Number
FDA product code
LDF
EMDN code
C020280 Temporary cardiac electrical stimulation devices - accessories
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.3680
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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: Electrical-only medical device connection cable, single-use

Similar devices in this category

Other devices filed under CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES).

Other devices from Shenzhen Launch Electrical Co., Ltd

See all devices from Shenzhen Launch Electrical Co., Ltd →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)