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ROCHE DIABETES CARE, INC.

USA · Burgdorf

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 9 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

11listed device types

Class I 2Class II 8Class III 1

plus 19 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class I 4Class II 16

60 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

8active device licences

Class II 3Class III 5

30 including historic records

TWTaiwanTFDA

18valid device licences

Class I 5Class II 13

SGSingaporeHSA SMDR

8device registrations

CLASS B 3CLASS C 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 1IVD import 2

AUAustraliaTGA ARTG

16active ARTG entries

Class I 1IVD Class 1 1IVD Class 3 2IIa 9IIb 3

HKHong KongMDACS

12valid listings

Class II 5IVD C 7

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 States19 registration records, 13 510(k), 0 PMA, 29 excluded

Brazil20 confirmed, 3 excluded

Saudi Arabia3 confirmed, 1 excluded

Canada8 confirmed, 6 excluded

Manufacturer names merged into this page: ROCHE DIABETES CARE, INC. · Roche Diabetes Care GmbH · ROCHE DIABETES CARE AG · ROCHE DIABETES CARE GMBH · ROCHE DIABETES CARE BRASIL LTDA · Roche Diabetes Care GMBH

FDA 510(k) clearances by year

12012

12015

12016

12018

52022 · K220849

42023 · K232488

FDA listed device types

showing 8 of 11

Pump, Infusion, Insulin 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Accessories, Pump, Infusion 1Multiple Use Blood Lancet For Single Patient Use Only 1Calculator, Drug Dose 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Calprotectin, Fecal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232488	Accu-Chek Safe-T-Pro Plus Lancing Device	2023-11-13
US	K232509	Accu-Chek Safe-T-Pro Uno Lancing Device	2023-11-13
US	K213134	Accu-Chek Solo micropump system with interoperable technology	2023-08-10
BR	81414021707	Accu-Chek Solo INFUSION ASSEMBLY	Class II
BR	81414029002	Accu-Chek Solo PUMP BASE	Class II
BR	81414021705	Accu-Chek Solo INSERTION DEVICE	Class I
SA	ME0000015127SFDAA00003	Roche Diabetes Care Platform	—
SA	ME0000015127SFDAA00008	Accu-Chek Smart Pix Device Reader	—
CA	11261	INFUSION SETS FOR DISETRONIC MICRO DOSE PUMPS	Class II
CA	109743	ROCHEDIABETES CARE PLATFORM	Class II
CA	2688	BLOOD GLUCOSE MONITORS	Class III

ROCHE DIABETES CARE, INC.

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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