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PowerPack 309-004R

by Microline Surgical, Inc.

Ref 309-004R

PowerPack 309-004R is a device classified as Class IIb in the EU and Class II in the US made by Microline Surgical, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 081109901DOC011S8) and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 00811099011606), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081109901DOC011S8 Basic UDI-DI 00811099011606UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811099011606 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081109901DOC011S8 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 00811099011606 listed 13 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00811099011606
  2. Registered EUDAMED 081109901DOC011S8

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  • Withdrawn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
Microline Dual Control Footswitch EUDAMED
PowerPack GUDID
Generic name
Foot-switch, electrical
Model / Ref / Catalog
309-004R
Primary DI / UDI-DI
00811099011606
Basic UDI-DI
081109901DOC011S8
FDA product code
GEI
EMDN code
K020180 Single- and bipolar devices, single use - accessories
GMDN term
Foot-switch, electrical
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Foot-switch, electrical

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See all devices from Microline Surgical, Inc. →

Properties

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