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Healthium Medtech Limited

India · Bangalore · www.healthiummedtech.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN IN-MF-000008421

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

3UDI-DI device records

Class I 3

USUnited StatesFDA openFDA

27listed device types

Class I 12Class II 14Class III 1

plus 41 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

60registered device records

Class I 28Class IIa 5Class IIb 7Class III 20

BRBrazilANVISA

15registered devices

Class I 3Class II 12

30 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

11valid device licences

Class I 1Class II 10

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

72active ARTG entries

Class I 32Class III 17IIa 12IIb 10Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 Union3 raw hits, 0 excluded, 3 confirmed

United States41 registration records, 5 510(k), 0 PMA

United Kingdom60 confirmed, 0 excluded

Brazil15 confirmed, 0 excluded

Manufacturer names merged into this page: HEALTHIUM MEDTECH LIMITED · HEALTHIUM MEDTECH LIMITED

Regulatory identity

EU manufacturer SRN: IN-MF-000008421
EU authorised representative: Meddevices Lifesciences B.V.
UK responsible person: Meddevices Services Limited

Business registration

LEI: 335800DXWV6WS6TZQT97
Registration status: Active
Legal form: Public Limited Company (Ltd)
Incorporated: 1992-12-27
Registered address: 472,/D, 4TH PHASE, 13TH, BANGALORE, 560058
Registration authority: Companies Register, no. U03311KA1992PLC013831
Registry record updated: 2025-11-07

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

42023 · K230891

12024 · K231033

FDA listed device types

showing 8 of 27

Instrument, Bending Or Contouring 1Reamer 1Probe 1Camera, Television, Endoscopic, Without Audio 1Bit, Drill 1Gauge, Depth 1Applier, Surgical, Clip 1Camera, Surgical And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08903837729439	Visualization system 4k -Console	Class I
EU	08903837729446	Visualization system 4K-Camera Head	Class I
EU	08903837729453	Visualization system 4K- Light Cable	Class I
UK	47862	Calibrated Probe	Class I
UK	58752	Sterile Guiding cannula	Class I
UK	66531	ACL JIG Complete Set	Class I
US	K231033	CEPTRE® Knotted UHMWPE Suture PEEK Anchor	2024-01-04
US	K230891	SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant	2023-12-28
US	K232886	INFILOOP® Fixed Loop UHMWPE Suture Titanium Button	2023-11-08
BR	81504799175	X-Tract	Class II
BR	81504799176	Aplicador Trutie	Class II
BR	81504799177	SurgiPler	Class II