Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027518263

FEI Number

3027518263

Entity Name

ONEHALF DESIGN CO.,LTD

City/State/Country

Jinan Shandong, CN

Establishment Address

302, Plant 2, No.8 Zidong Avenue, Tianqiao District, Jinan Shandong 250000, CN

Establishment Type(s)

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

Owner / Operator

OneHalf Design Co.,LTD (Owner Number: 10087960)

Owner / Operator Contact Address

302, Plant 2, No.8 Zidong Avenue, Tianqiao District, Jinan, CN-SD 250000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Advanced Abdominal Simulation Trainer Box (Teaching), Abdominal Single-port Trainer Box (Teaching), 3D Suture Module (Teaching), Positioning Skin Module (Teaching), Stripping Module (Teaching), Foldable Trainer Box (Teaching), Hemispheric Trainer Box (Teaching), Endoscopic Fenestrated Grasper (Teaching), Endoscopic Scissor (Teaching) Banding Training Module (Teaching), Trocar (Teaching), Straight Rod Endoscope (Teaching), Perforation Module (Teaching), Intestinal Module (Teaching), Clip Module (Teaching), Clamping Module (Teaching), Precision Cutting Module (Teaching) Endoscopic Needle Holder (Teaching), Endoscopic Dissecting Forceps (Teaching),

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEA	Attachment, Teaching, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2023-05-06

Official Correspondent

Luyang Guo

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

OneHalf Design Co.,LTD

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 3027518263. Last updated year: 2026. Please use registration number 3027518263 when referencing this establishment in official correspondence.