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VITAL HEALTHCARE SDN.BHD.

✓ Record-verifiedregistrations found in 12 marketsEU SRN MY-MF-000005704

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥267, the first 300 verified individually. 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

≥267UDI-DI device records

Class IIa 216Class IIb 51

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 1Class IIb 1

BRBrazilANVISA

9registered devices

Class II 9

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

2active device licences

Class II 2

3 including historic records

TWTaiwanTFDA

9valid device licences

Class II 9

SGSingaporeHSA SMDR

6device registrations

CLASS B 5CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

8active ARTG entries

IIa 6IIb 2

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

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.

European Union1,850 raw hits, 33 excluded, 267 confirmed. Large result set — only the first 300 verified

United States5 registration records, 3 510(k), 0 PMA, 27 excluded

United Kingdom2 confirmed, 11 excluded

Brazil9 confirmed, 3 excluded

Canada2 confirmed, 7 excluded

Manufacturer names merged into this page: VITAL HEALTHCARE (GUANGZHOU) CO., LTD. · VITAL HEALTHCARE SDN. BHD. · VITAL SIGNS, INC. A GE HEALTHCARE COMPANY

Regulatory identity

EU manufacturer SRN: MY-MF-000005704
EU authorised representative: Medical Technology Promedt Consulting GmbH
UK responsible person: Medimap Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09551032477274	Disposable AV Fistula Needle Sets (Safety Needle Series)	Class IIa
EU	09551032477267	Disposable AV Fistula Needle Sets (Safety Needle Series)	Class IIa
EU	09551032477250	Disposable AV Fistula Needle Sets (Safety Needle Series)	Class IIa
EU	09551032477243	Disposable AV Fistula Needle Sets (Safety Needle Series)	Class IIa
UK	34999	NovaLine Tubing Sets for Hemodialysis	Class IIa
UK	47072	Hollow Fiber Dialyzer	Class IIb
US	K251341	VITAL Tubing Sets for Hemodialysis	2026-01-16
US	K130867	ENFLOW IV FLUID WARMER INSULATED STRAP	2013-06-14
US	K121775	ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER	2012-11-28
BR	80263409035	LINHA SANGUÍNEA ARTERIAL PARA HEMODIÁLISE RMDESC	Class II
BR	82551839006	Jogos de agulhas para fístula arteriovenosa	Class II
BR	81504799105	LINHA ARTERIAL PARA HEMODIÁLISE	Class II
CA	68981	C-CO2 COLORIMETRIC CO2 INDICATOR	Class II
CA	100650	NOVALINE TUBING SETS FOR HEMODIALYSIS	Class II

VITAL HEALTHCARE SDN.BHD.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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