Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011459664

FEI Number

3011459664

Entity Name

QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Qingdao Shandong, CN

Establishment Address

No.100 Keyuanweisi Rd., Qingdao Shandong 266100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Qingdao O-Mec Medical Technology Co., Ltd. (Owner Number: 10048000)

Owner / Operator Contact Address

No.100 Keyuanweisi Rd., Qingdao, CN-SD 266100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-Mount Right Angle Coupler SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 70°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 70°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 12°, 30 cm O-Adapter, Speed-lock, Cystoscope SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 12°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 0°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 0°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4 mm x 30°, 30 cm SPY Cystoscope/Hysteroscope, Autoclavable, Speed-Lock, 4 mm x 30°, 30 cm O-Mec 690 Series Laparoscopes SPY Laparoscope, Autoclavable, 5.4 mm x 30, 30cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 30, 45cm SPY Laparoscope, Autoclavable, 5.4 mm x 45, 30cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 30, 45cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 45, 45cm SPY Laparoscope, Autoclavable, 10mm x 30, 33cm SPY Laparoscope, Autoclavable, 5.4 mm x 0, 30cm SPY Laparoscope, Autoclavable, 10mm x 45, 33cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 45, 45cm SPY Bariatric Laparoscope, Autoclavable, 5.4 mm x 0, 45cm SPY Laparoscope, Autoclavable, 10mm x 0, 33cm SPY Bariatric Laparoscope, Autoclavable, 10mm x 0, 45cm IRF Laparoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2014-11-24
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-02-13
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2024-02-13
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-02-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-07-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-07-07
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2015-03-19

Official Correspondent

Linda Cong

US Agent Details

Claire Nippress Business: OMEC Medical NV Inc. Email: clairen@omecmedical.com Phone: (775) 3606339

Related Public Records

Same Entity

Qingdao O-Mec Medical Technology Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, 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 3011459664. Last updated year: 2026. Please use registration number 3011459664 when referencing this establishment in official correspondence.