Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005182157

FEI Number

3005182157

Entity Name

HIMEDIA LABORATORIES PRIVATE LIMITED

City/State/Country

DOMBIVLI, THANE Maharashtra, IN

Establishment Address

W-239 B, M.I.D.C., PHASE II, DOMBIVLI, THANE Maharashtra 421 204, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Himedia Laboratories Private Limited (Owner Number: 9073586)

Owner / Operator Contact Address

C40 Road No. 21Y, MIDC, Wagle Industrial Area, Thane, IN-NOTA 400604, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Annexure 6 Annexure 15 Annexure 3 Annexure 8 Annexure 9 Annexure 12 ANNEXURE 5 TL1158, TL1159 & TL1031 Annexure 7 Annexure 11 Trypsin 0.25% Solution 1 0.25% Trypsin in Dulbecco's Phospha Annexure 2 Annexure 10 Annexure 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2005-05-27
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2009-11-17
JSC	Culture Media, General Nutrient Broth	Microbiology	Class 1	866.2350	2005-05-27
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2005-05-27
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2005-05-27
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2008-04-26
JSE	Culture Media, Multiple Biochemical Test	Microbiology	Class 1	866.2320	2005-05-27
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2005-05-27
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2005-05-27
JSB	Culture Media, Vitamin Assay	Microbiology	Class 1	866.2350	2005-05-27
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2005-05-27
JSA	Culture Media, Antibiotic Assay	Microbiology	Class 1	866.2350	2005-05-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Himedia Laboratories Private Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005182159	HIMEDIA LABORATORIES PRIVATE LIMITED	NASHIK Maharashtra, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822995	Granite Diagnostics, Inc.	ANDRADES FERMENTATION MEDIA	1982-11-16
K880126	Hardy Media	LAURYL TRYPTOSE BROTH	1988-03-31
K821594	Hardy Media	UREA AGAR SLANT	1982-07-08
K790620	Anaerobe Systems	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	1979-04-23
K811056	Acumedia Manufacturers, Inc.	BRAIN HEART INFUSION	1981-04-29

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005182157. Last updated year: 2026. Please use registration number 3005182157 when referencing this establishment in official correspondence.