Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015468226

FEI Number

3015468226

Entity Name

MAGNATEK ENTERPRISES

City/State/Country

Sangareddy Telangana, IN

Establishment Address

Plot no. M57 Medical Devices Park,, SY NO: 70, 174, Sultanpur Village Hyderabad, Sangareddy Telangana 502319, IN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Magnatek Enterprises (Owner Number: 10060357)

Owner / Operator Contact Address

#97, SVC Industrial Estate, Balanagar, Rangareddy, IN-TG 500037, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical /Surgical / Examination Lights with Camera Medical / Surgical/Operation Theatre Lights(Magnaled Series) Display Recording & Transmission Systems with Communications Integration of Audio & Video Communication Medical/ Hospital Pendants Magnum Series(ERP, ESP, TRP, TSP, TEP series) & Bed Head Panels Surgical Examination & Procedure Lights with all related Accessories & Attachments Chemotherapy Chairs Dialysis Chair; Dialysis Chairs Diastar/ Diacomfy Series Dialysis Chair Dialysis Chairs Diastar/ Diacomfy Series with all related Accessories & Attachments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2019-04-30
FIA	Chair, Dialysis, Unpowered, Without Scales	Gastroenterology, Urology	Class 1	876.5820	2019-04-30

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

Magnatek Enterprises

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
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015468226. Last updated year: 2026. Please use registration number 3015468226 when referencing this establishment in official correspondence.