Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043604863

FEI Number

3043604863

Entity Name

Alkem MedTech Pvt. Ltd.

City/State/Country

Thane Maharashtra, IN

Establishment Address

Office no - 301, 3rd floor, Plot No. A-22, TTC Industrial Area, Khairane, Thane Maharashtra 400705, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alkem MedTech Pvt. Ltd. (Owner Number: 10095047)

Owner / Operator Contact Address

Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai, IN-MH 400013, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SafeLavage SafeTrion Battery Funnel SafeTrion Extended Battery Docking Station SafeTrion Mains Cable SafeTrion Reciprocating/Sternum Saw Attachment SafeTrion Intramedullary Rigid Reamer Shaft with Fixed Drilling Head SafeTrion K-Wire Driver Attachment SafeTrion Battery Pack SafeTrion Pin Driver Attachment SafeTrion Cannulated Reaming Attachment SafeTrion Sternum Guard SafeTrion Sternum saw blade SafeTrion Oscillating Saw Blades SafeTrion Acetabular reamer set Shaft SafeTrionHandpiece SafeTrion Cannulated drill bit SafeTrion Battery Docking Station SafeTrion AO Drill bit SafeTrion Drill Bit SafeTrion Sagittal Saw Attachment SafeTrion Intramedullary Flexible Reamer Shaft with Fixed Drilling Head SafeTrion Saggital Saw Blades SafeTrion Pin Drivers SafeTrion Jacob Chuck Key SafeTrion Intramedullary Flexible Reamer Shaft with Fixed Blunt Head SafeTrion Acetabular Reaming Attachment SafeTrion Reciprocating Saw Blades SafeTrion Intramedullary Flexible Reamer Shaft with Fixed Drill Tip SafeTrion Drill Attachment with Jacob Chuck SafeTrion AO cannulated drill bit SafeTrion Shank Drill bit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-01-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-01-19

Official Correspondent

Vilas Khade

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (570) 1516482

Related Public Records

Same Entity

Alkem MedTech Pvt. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

Similar Registrations

Registration Number	Establishment Name	Location
3032611331	CALEB CO., LTD.	Won-Ju-Si Gangwon, KR
3012964172	ELITE MEDTEK(JIANGSU) CO., LTD	Changzhou City Jiangsu, CN
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043604863. Last updated year: 2026. Please use registration number 3043604863 when referencing this establishment in official correspondence.