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9215000000

by Stryker Corp.

Ref 9215-000-000Model 08858251006140SX

9215000000 (9215-000-000) is a Class I device made by Stryker Corp., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 08858251006140SX) and listed in FDA GUDID since 4 Nov 2022 (UDI-DI 07613327468458), 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 Number08858251006140SX Basic UDI-DI 07613327468458UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327468458 UDI-DI Date4 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006140SX registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 07613327468458 listed 4 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327468458
  2. Registered EUDAMED 08858251006140SX

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  • Withdrawn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 9
Generic name
Portable/mobile rechargeable battery pack
Device name
Sterile Batteries
Model / Ref / Catalog
08858251006140SX, 9215-000-000, 9215000000
Primary DI / UDI-DI
07613327468458
Basic UDI-DI
08858251006140SX
Direct marketing DI
07613327468458
FDA product code
MOQ, OUG
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class I
Regulation number
878.4820, 880.6310
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
08858251006140SX
9215-000-000
GUDID
9215000000

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

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)