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Novo Nordisk (China) Pharmaceuticals, Co. Ltd.

China · Tianjin

✓ 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 31 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 1Class II 8

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

6active device licences

Class II 6

17 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 States31 registration records, 19 510(k), 0 PMA, 2 excluded

Brazil9 confirmed, 0 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI · NOVO NORDISK A/S · NOVO NORDISK INC. · Novo Nordisk (China) Pharmaceuticals, Co. Ltd. · NOVO NORDISK CANADA INC. · NOVO NORDISK A/S NOVO NORDISK (CHINA) PHARMACEUTICALS CO. LTD.

Same-named companies — This database also contains companies with near-identical names: Novo Nordisk, Inc., NOVO NORDISK A/S, NOVO NORDISK A/S NOVO NORDISK (CHINA) PHARMACEUTICALS CO. LTD., NOVO NORDISK CANADA INC.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11990

11991

11993

11995

12001

22005

12006

22010

12013

12014

12015

12016

22018

12020

12021

12023

FDA listed device types

I.V. Start Kit 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1Introducer, Syringe Needle 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231255	NovoFine® Plus	2023-08-25
US	K210258	NovoFine	2021-06-23
US	K202005	NovoFine Plus 32G Tip x 4 mm	2020-12-19
BR	82113069007	DuraTouch®	Class II
BR	82113069001	NovoFine 32G 4 mm	Class II
BR	82113069005	NovoPen 4	Class II
CA	13998	INNOVO	Class II
CA	80986	NORDIPEN	Class II
CA	82588	NIASTASE RT INFUSION KIT	Class II

Novo Nordisk (China) Pharmaceuticals, Co. 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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