R82 A/S

Denmark · Gedved Midtjylland

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Israel — 4 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

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States9 registration records, 5 510(k), 0 PMA

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: R82 A/S

FDA 510(k) clearances by year

12003 · K030882

12004 · K033460

12006 · K061810

12010 · K100084

12016 · K151492

FDA listed device types

showing 8 of 9

Wheelchair, Mechanical 1Table, Mechanical 1Adaptor, Hygiene 1Chair, Adjustable, Mechanical 1Accessories, Wheelchair 1Stroller, Adaptive 1Table, Powered 1Walker, Mechanical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151492	Kudu	2016-05-20
US	K100084	MULTI FRAME WHEELCHAIR	2010-04-12
US	K061810	COUGAR WHEELCHAIR	2006-08-07
BR	81137420009	Seating R82	Class I
BR	81137420011	SCALLOP	Class I
BR	81137420008	CRICKET	Class I

R82 A/S

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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