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BioHorizons IS220Z

by Biohorizons Implant Systems Inc.

Ref IS220ZModel IntraSpin Centrifuge

BioHorizons IS220Z is a device classified as Class IIa in the EU and Class II in the US made by Biohorizons Implant Systems Inc., registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 08472360IIAACTIVE001Z4), listed under FDA premarket submission BK120048 and listed in FDA GUDID since 7 Oct 2020 (UDI-DI 00847236015824), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK120048

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08472360IIAACTIVE001Z4 Basic UDI-DI 00847236015824UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236015824 UDI-DI Date7 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK120048 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08472360IIAACTIVE001Z4 registered 9 Jul 2026 Active
  • FDA premarket submission BK120048 Active
  • FDA GUDID UDI-DI 00847236015824 listed 7 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847236015824
  2. Registered EUDAMED 08472360IIAACTIVE001Z4

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  • Withdrawn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
BioHorizons
Generic name
Haematological concentrate system
Device name
Centrifuge
Model / reference
IS220Z, IntraSpin Centrifuge
Primary DI / UDI-DI
00847236015824
Basic UDI-DI
08472360IIAACTIVE001Z4
FDA product code
ORG
EMDN code
Z12110101 Dental treatment units
GMDN term
Haematological concentrate system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.9245
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Haematological concentrate system

Cleared under the same submission (BK120048)

and 8 more cleared under BK120048

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)