Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007591382

FEI Number

3007591382

Entity Name

AMTAI MEDICAL EQUIPMENT, INC.

City/State/Country

Raleigh, NC, US

Establishment Address

5605 PRIMAVERA CT, Raleigh, NC 27616, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMTAI Medical Equipment, Inc. (Owner Number: 10029286)

Owner / Operator Contact Address

5605 Primavera Ct, Raleigh, NC 27616, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMTAI AMTAI AMTAI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2009-04-27
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2015-06-01
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2015-06-01

Official Correspondent

Alan Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMTAI Medical Equipment, Inc.

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-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-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

Similar Registrations

Registration Number	Establishment Name	Location
3031025858	HERR ENTERPRISES INC	Jasper, AL, US
3006800085	IHB OPERATIONS	Zwolle Overijssel, NL
3044829820	UNITED SURGICAL INDUSTRIES	SAHIBABAD Uttar Pradesh, IN
3007836437	HOSMED INC.	Doral, FL, US
3006105501	DRASHTI MEDICAL SOLUTIONS, LLC	Rockledge, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007591382. Last updated year: 2026. Please use registration number 3007591382 when referencing this establishment in official correspondence.