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6127120000

by Stryker Corp.

Part of a family of 14 devices: see the family page

Ref 6127-120-000Model 08858251002179SW

6127120000 is a Class I device made by Stryker Corp., registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 08858251002179SW) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 04546540550651), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002179SW Basic UDI-DI 04546540550651UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540550651 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002179SW registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04546540550651 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540550651
  2. Registered EUDAMED 08858251002179SW

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  • Withdrawn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
System 6
Generic name
Portable/mobile rechargeable battery pack
Device name
Heavy Duty Charger Modules, Housings and Shields
Model / Ref / Catalog
08858251002179SW EUDAMED
6127-120-000 EUDAMED
6127120000 GUDID
Primary DI / UDI-DI
04546540550651
Basic UDI-DI
08858251002179SW
Direct marketing DI
04546540550651
FDA product code
HWE
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class I
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002179SW
6127-120-000
GUDID
6127120000

Related devices

Category: Portable/mobile rechargeable battery pack

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)