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COCHLEAR BONE ANCHORED SOLUTION AB

Sweden

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 2Class II 6Class III 0

plus 25 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 6Class III 1

18 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States25 registration records, 2 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: COCHLEAR BONE ANCHORED SOLUTIONS AB · COCHLEAR BONE ANCHORED SOLUTION AB

Same-named companies — This database also contains companies with near-identical names: COCHLEAR BONE ANCHORED SOLUTIONS AB, Cochlear Bone Anchored Systems AB. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008 · K080363

12009 · K090720

FDA listed device types

Active Implantable Bone Conduction Hearing System 1Hearing Aid, Bone Conduction 1Prosthesis, Nose, Internal 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Bone Conduction, Implanted 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Motor, Surgical Instrument, Ac-Powered 1Instrument, Ent Manual Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090720	COCHLEAR BAHA BP100	2009-06-17
US	K080363	BAHA CORDELLE II	2008-04-10
BR	10178010293	PROCESSADOR BAHA 5 SUPER POWER	Class II
BR	10178010285	Kit Instrumental Reusável BAHA Attract	Class I
BR	10178010232	BROCA CIRÚRGICA DESCARTÁVEL BAHA	Class II
CA	64754	BAHA DERMATOME	Class II
CA	65166	BAHA BLADE	Class II
CA	67547	BAHA DIVINO DIGITAL IMPLANTABLE HEARING AID	Class III

COCHLEAR BONE ANCHORED SOLUTION AB

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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