Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680168

FEI Number

1000295034

Entity Name

UNITED POLY ENGINEERING PVT. LTD.

City/State/Country

NEW DELHI, IN

Establishment Address

D-13/3 OKHLA INDUSTRIAL AREA, PHASE II, NEW DELHI 110020, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UNITED POLY ENGINEERING PVT. LTD. (Owner Number: 9007101)

Owner / Operator Contact Address

D-13/3 OKHLA INDUSTRIAL AREA, PHASE II, NEW DELHI, IN-DL 110020, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL UPL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWY	Table, Operating-Room, Non-Electrical	General, Plastic Surgery	Class 1	878.4950	2011-04-26
INY	Bed, Patient Rotation, Manual	Physical Medicine	Class 1	890.5180	2011-04-26
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2004-03-29
FZK	Chair, Surgical, Non-Electrical	General, Plastic Surgery	Class 1	878.4950	2011-04-26
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2011-04-26
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2011-04-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2004-03-29
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-03-29
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2011-04-26
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2011-04-26
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2004-03-29
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2011-04-26
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2004-04-21
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2011-04-26
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2004-03-29
FOB	Bedpan	General Hospital	Class 1	880.6730	2004-03-29
NOI	Stand, Instrument, Ophthalmic, Battery Powered	Ophthalmic	Class 1	886.1860	2011-04-26
HRE	Cabinet, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2011-04-26
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2011-04-26
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2011-04-26
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2011-04-26
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2011-04-26
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2005-02-28
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2011-04-26
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2011-04-26
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2011-04-26
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2011-04-26
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2011-04-26
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1997-03-18
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2011-04-11
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2011-04-26

Official Correspondent

ASHISH GROVER

US Agent Details

Shilpa Gampa Business: FREYR INC Email: usagent@freyrsolutions.com Phone: (760) 5834401

Related Public Records

Same Entity

UNITED POLY ENGINEERING 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
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680168. Last updated year: 2026. Please use registration number 9680168 when referencing this establishment in official correspondence.