Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009608361

FEI Number

3009608361

Entity Name

ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

No 16 Cuiming Road Yat-Sen Scientific In, Tianjin Economic Technological Developme, Tianjin 301726, CN

Establishment Type(s)

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

Owner / Operator

ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. (Owner Number: 10040720)

Owner / Operator Contact Address

No 16 Cuiming Road Yat-Sen Scientific In, Tianjin Economic Technological Developme, Tianjin, CN-TJ 301726, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intra OS DG Intra Os 70 DF-211H RADIOGRAPHIC X-RAY SYSTEM Disposable Medical Mask Medical Surgical Mask FS-500DDR KN95 Mask N95 Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2017-02-23
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-05-10
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2016-12-28
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25

Official Correspondent

Jia Song

US Agent Details

Jun Peng Business: P&L Scientific Inc. Email: jpeng@plscientificinc.com Phone: (305) 3456018

Related Public Records

Same Entity

ORICH MEDICAL EQUIPMENT (TIANJIN) CO., 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
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21
K123106	Samsung Electronics Co., Ltd.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
K203340	Siemens Medical Solutions USA, Inc.	MULTIX Impact C	2021-01-06
K230241	Sg Healthcare Co, Ltd.	Jumong General	2023-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3007933232	DIGIMED CO., LTD	Seoul, KR
3003528079	XLINE SRL	ASSAGO Milano, IT
3002994636	DE GOTZEN S.R.L.	FAGNANO OLONA Varese, IT
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009608361. Last updated year: 2026. Please use registration number 3009608361 when referencing this establishment in official correspondence.