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BIOSORB BIO1 Granules

by S.B.M 9 variants

Ref P822692644Model Granules for filling

BIOSORB BIO1 Granules (P822692644) is a device classified as Class III in the EU and Class II in the US made by S.B.M, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-03760154000451), cleared under FDA 510(k) K021963 on 28 Jan 2003 and listed in FDA GUDID since 13 Oct 2015 (UDI-DI 03760154000451), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021963

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154000451 Basic UDI-DI 03760154000451UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154000451 UDI-DI Date13 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK021963 Date28 Jan 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154000451 registered 2 Nov 2026 Active
  • FDA 510(k) K021963 decided 28 Jan 2003 Active
  • FDA GUDID UDI-DI 03760154000451 listed 13 Oct 2015 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1718-2025 FDA Class II initiated 7 Apr 2025

    Vials of implant bone granules may contain less product then specified on labeling.

Timeline

4 dated events

  1. Cleared FDA 510(k) K021963
  2. Listed FDA GUDID 03760154000451
  3. Recall initiated FDA recalls Z-1718-2025
  4. Registered EUDAMED B-03760154000451

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bio 1 EUDAMED
Biosorb GUDID
Generic name
Synthetic bone graft
Model / Ref / Catalog
Granules for filling, P822692644, BIO1 Granules
Primary DI / UDI-DI
03760154000451
Basic UDI-DI
B-03760154000451
510(k) Number
FDA product code
MQV
EMDN code
P900402 Resorbable filling and reconstruction devices
GMDN term
Synthetic bone graft
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3045
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter
Outer Diameter — 3 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Granules for filling
P822692644
GUDID
BIO1 Granules
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Synthetic bone graft

Cleared under the same submission (K021963)

and 5 more cleared under K021963

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)