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Accumax Lab Devices Pvt. Ltd.

India · Gandhinagar · www.accumaxlab.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN IN-MF-000028076

This company has registrations in European Union, United States, Brazil, Australia, Israel, Russia — 6 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

59UDI-DI device records

IVD A 13IVD general 46

USUnited StatesFDA openFDA

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 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 Union59 raw hits, 0 excluded, 59 confirmed

United States7 registration records, 0 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: ACCUMAX LAB DEVICES PVT LTD · ACCUMAX LAB DEVICES PRIVATE LIMITED. · ACCUMAX LAB DEVICES PRIVATE LIMITED

Regulatory identity

EU manufacturer SRN: IN-MF-000028076
EU authorised representative: mdi Europa GmbH

Business registration

Legal name: ACCUMAX LAB DEVICES PRIVATE LIMITED
LEI: 335800NZLH8X2I3CUI75
Registration status: Active
Legal form: Private Limited Company (Pvt Ltd)
Incorporated: 2009-05-14
Registered address: PLOT NO.228/1/4, DANTALI INDUSTRIAL OWNERS ASSOCIATION, DANTALI, KALOL, KALOL, 382725
Registration authority: Companies Register, no. U33110GJ2009PTC056957
Registry record updated: 2026-08-13

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

FDA listed device types

Container, Specimen Mailer And Storage, Sterile 1Container, Specimen, Sterile 1Container, Specimen, Non-Sterile 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Micro Pipette 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Station, Pipetting And Diluting, For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-TIPS30MM	—	IVD general
EU	D-TIPS21ML	—	IVD general
EU	D-TIPS20MJ	—	IVD general
EU	D-TIPS19MZ	—	IVD general
BR	80884880035	Microcentrífuga	Class I
BR	82634829023	Centrífuga NEAUTION	Class II
BR	80884880036	Centrífuga Refrigerada	Class I

Accumax Lab Devices Pvt. Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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