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Biomet® 800-0508

by Biomet Orthopedics, Inc.

Ref 800-0508

Biomet® 800-0508 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 889024ACDYY) and listed in FDA GUDID since 11 Jun 2019 (UDI-DI 00880304400085), 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 Number889024ACDYY Basic UDI-DI 00880304400085UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304400085 UDI-DI Date11 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024ACDYY registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00880304400085 listed 11 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00880304400085
  2. Registered EUDAMED 889024ACDYY

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  • Withdrawn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
Biomet®
Generic name
Centrifuge tube counterbalance
Device name
Biomet Counterbalance
Model / Ref / Catalog
800-0508
Primary DI / UDI-DI
00880304400085
Basic UDI-DI
889024ACDYY
FDA product code
JQC
EMDN code
B06 Cellular or biological manipulation devices
GMDN term
Centrifuge tube counterbalance
Device class
Class I
Regulation number
862.2050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Centrifuge tube counterbalance

Similar devices in this category

Other devices filed under CELLULAR OR BIOLOGICAL MANIPULATION DEVICES.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)