HomeIndiaAuxein Medical Private Limited

Auxein Medical Private Limited

India · Sonepat · www.auxein.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
83listed device types
Class I 72Class II 11Class III 0
plus 91 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
11registered devices
Class I 11
16 including historic records
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
8active ARTG entries
Class I 2IIb 6
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 States91 registration records, 15 510(k), 0 PMA
Brazil11 confirmed, 0 excluded
Manufacturer names merged into this page: Auxein medical Private limited · AUXEIN MEDICAL PVT. LTD

Company information

Country
India
City
Sonepat
Website
www.auxein.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationTrauma systems

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
2549007UT21PLMMCTA51
Registration status
Active
Legal form
Private Limited Company (Pvt Ltd)
Incorporated
2012-09-03
Registered address
7-A, Nirankari Colony, Gali No. 1, Near Kingsway Camp Road, North Delhi, Delhi, 110009
Registration authority
Companies Register, no. U33110DL2012PTC241539
Registry record updated
2025-12-10

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

12015
12020
32021
72022 · K213110
22023 · K221787
12024 · K240181

FDA listed device types

showing 8 of 83
Template 1Elevator 1Container, Specimen, Sterile 1Probe 1Pusher, Socket 1Spinal Channeling Instrument, Vertebroplasty 1Scissors, Orthopedic, Surgical 1Clamp 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240181Clavicle and Scapula System2024-10-09
USK221787Auxein's DHS/DCS Plate System2023-11-30
USK213059Tibia and Fibula System2023-01-27
BR81118630051Auxein Surgical Instruments - PolymerClass I
BR81118630052Auxein Surgical Instruments - MetallicClass I
BR81118630031Auxein Surgical Instruments - TitaniumClass I

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