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Baha 92129

by Cochlear Bone Anchored Solutions AB

Ref 92129

Baha 92129 is a device classified as Class IIb in the EU and Class II in the US made by Cochlear Bone Anchored Solutions AB, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 9321502BI300HJ), cleared under FDA 510(k) K100360 on 13 Jul 2010 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 09321502019545), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100360

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/MDR EUDAMED Number9321502BI300HJ Basic UDI-DI 09321502019545UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09321502019545 UDI-DI Date22 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK100360 Date13 Jul 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9321502BI300HJ registered 26 Aug 2026 Active
  • FDA 510(k) K100360 decided 13 Jul 2010 Active
  • FDA GUDID UDI-DI 09321502019545 listed 22 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K100360
  2. Listed FDA GUDID 09321502019545
  3. Registered EUDAMED 9321502BI300HJ

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  • Withdrawn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
Cochlear® BI300 Implant 4 mm EUDAMED
Baha GUDID
Generic name
Craniofacial bone screw, non-bioabsorbable
Device name
BI300 Implant
Model / Ref / Catalog
92129
Primary DI / UDI-DI
09321502019545
Basic UDI-DI
9321502BI300HJ
510(k) Number
FDA product code
LXB
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
874.3302
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Conditional
Size
Length — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 09321502019545: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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: Craniofacial bone screw, non-bioabsorbable

Cleared under the same submission (K100360)

and 8 more cleared under K100360

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Cochlear Bone Anchored Solutions AB

See all devices from Cochlear Bone Anchored Solutions AB →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)