Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009401905

FEI Number

3009401905

Entity Name

ADROIT MANUFACTURING CO.

City/State/Country

Umbergaon Gujarat, IN

Establishment Address

Plot No: 138 (EXPN, AREA), GIDC, Dist. Valsad, Umbergaon Gujarat 396171, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADROIT MANUFACTURING CO. (Owner Number: 10040349)

Owner / Operator Contact Address

Plot No: 138, Dist. Valsad, Umbergaon, IN-GJ 396171, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K000117

PMA Number

N/A

All Registered Proprietary Names

SET, ANESTHESIA,PARACERVICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEE	Set, Anesthesia, Paracervical	Obstetrics/Gynecology	Class 2	884.5100	2023-08-08

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Dassler Business: SPECTRA MEDICAL DEVICES, LLC Email: kdassler@spectramedical.com Phone: (978) 6570889

Related Public Records

Same Entity

ADROIT MANUFACTURING CO.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009401905. Last updated year: 2026. Please use registration number 3009401905 when referencing this establishment in official correspondence.