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BSN MEDICAL (PTY) LTD.

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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

44listed device types

Class I 40Class II 2Class III 0unclassified 2

plus 113 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

100registered devices

Class I 94Class II 6

111 including historic records

SASaudi ArabiaSFDA

120registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

25 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

26active ARTG entries

Class I 21Class Is (sterile) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States113 registration records, 3 510(k), 0 PMA, 3 excluded

Brazil100 confirmed, 3 excluded

Saudi Arabia120 confirmed, 2 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: BSN Medical GmbH · BSN MEDICAL INC. · BSN medical Inc. · BSN Medical S.A. de C.V. · BSN MEDICAL GMBH · BSN MEDICAL INC

Same-named companies — This database also contains companies with near-identical names: BSN MEDICAL, INC., BSN MEDICAL SA DE CV, BSN MEDICAL LIMITADA, BSN medical Limitada (COLOMBIA). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12012 · K123561

12013 · K131496

12015 · K143151

FDA listed device types

showing 8 of 44

Pad, Eye 1Sling, Arm, Overhead Supported 1Orthosis, Lumbar 1Splint, Hand, And Components 1Support, Hernia 1Dressing, Wound, Occlusive 1Splint, Extremity, Noninflatable, External, Sterile 1Instrument, Cast Removal, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K143151	Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)	2015-01-26
US	K131496	BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)	2013-07-10
US	K123561	ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS	2012-12-18
BR	10224000056	Leukotape BSN	Class I
BR	10224000091	Actimove® Clavícula	Class I
BR	10224000108	Actimove® TaloCast-AirGel	Class I
SA	ME0000004305SFDAA00073	ACTIMOVE ES Mild Elbow support	—
SA	ME0000004305SFDAA00074	Leukoplast eye occlusor	—
CA	87556	JOBST COMPRIFORE LF	Class II
CA	87558	JOBST COMPRIFORE LITE LF	Class II
CA	98707	CUTIMED SORBION SACHET BORDER	Class II

BSN MEDICAL (PTY) LTD.

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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