Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006897899

FEI Number

3006897899

Entity Name

Global Medical Production Co. Ltd

City/State/Country

JiaXing Zhejiang, CN

Establishment Address

No. 4 Building, No.3288 West Zhongshan Road, Xiuzhou district, JiaXing Zhejiang 314031, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Global Medical Production Ltd (Owner Number: 10024263)

Owner / Operator Contact Address

No.4 Building, No. 3288 West Zhongshan, Road, Xiuzhou District, JiaXing, CN-ZJ 314031, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GUIDE, NEEDLE, SURGICAL Endoscope and Accessories Laparoscope, Gynecologic (And Accessories) Drape, Surgical Pneumoperitoneum Needle Electrosurgical, Cutting & Coagulation & Accessories Needle Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-08-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-02-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-02-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2014-02-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-02-20
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2014-02-20
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2024-07-09
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2016-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Athey Email: mathey@orangesurgical.com Phone: (407) 7564779

Related Public Records

Same Entity

Global Medical Production 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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006897899. Last updated year: 2026. Please use registration number 3006897899 when referencing this establishment in official correspondence.