Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005182159

FEI Number

3005182159

Entity Name

HIMEDIA LABORATORIES PRIVATE LIMITED

City/State/Country

NASHIK Maharashtra, IN

Establishment Address

B/4-6, M.I.D.C., PALKHED, DINDORI, NASHIK Maharashtra 422 202, 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 9 Annexure III Annexure 10 Annexure 14 0.25% Trypsin in Dulbecco's Phospha AL167 Viral Transport Medium MS2760 Annexure 12 Trypsin 0.25% Solution 1 0.25% Trypsin in Dulbecco's Phospha Annexure 2 Annexure 4 MS2760 TL1158, TL1159 & TL1031 AL167 Viral Transport Medium Annexure 3 Annexure 8 Annexure 11 TL1158, TL1159 & TL1031 Annexure 7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2005-05-27
JCF	Lymphocyte Separation Medium	Hematology	Class 1	864.8500	2014-01-07
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2005-05-27
IBG	Trypsin	Pathology	Class 1	864.4400	2009-11-17
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-11-24
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2008-04-26
JSB	Culture Media, Vitamin Assay	Microbiology	Class 1	866.2350	2005-05-27
JSD	Culture Media, Selective Broth	Microbiology	Class 1	866.2360	2005-05-27
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2020-11-24
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
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2005-05-27
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	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
3005182157	HIMEDIA LABORATORIES PRIVATE LIMITED	DOMBIVLI, THANE Maharashtra, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04
K811331	Acumedia Manufacturers, Inc.	SF BROTH	1981-05-29
K872058	Orion Corp.	ORICULT-N CULTURE-PADDLE	1987-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005182159. Last updated year: 2026. Please use registration number 3005182159 when referencing this establishment in official correspondence.