Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016680721

FEI Number

3016680721

Entity Name

WEIHAI DISHANG MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Weihai Shandong, CN

Establishment Address

No.220-3 Huoju Road, Torch Hi-tech Industrial Development Zone, Weihai Shandong 264200, CN

Establishment Type(s)

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

Owner / Operator

Weihai Dishang Medical Technology Co.,Ltd (Owner Number: 10062870)

Owner / Operator Contact Address

No.220-3 Huoju Road, Torch Hi-tech Industrial Development Zone, Weihai, CN-SD 264200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210355

PMA Number

N/A

All Registered Proprietary Names

Surgical Gown KN95 Protective Respirator Mask N95 Protective Respirator Mask SUPPORT,KNEE,ELASTIC,RETAIL,2XL, 2/CS Strap Set,Fetal Monitoring:Fetal Monitoring Strap Set Hook -and-Loop Closure,1-1/2?W*36?L Strap Set,Fetal Monitoring:Fetal Monitoring Strap Set with Button Closure,2-3/8?W*48?L Disposable Medical Operating Mask Disposable Protective Mask Disposable medical Mask Copper infused filtered mask Strap Set,Fetal Monitoring:Fetal Monitoring Strap Set Hook -and-Loop Closure,1-1/2?W*36?L Strap Set,Fetal Monitoring:Fetal Monitoring Strap Set with Button Closure,2-3/8?W*48?L BRACE,THUMB,W/ADJ STRPS,RETAIL,UNIV,4/CS Face shieId DSFS 2020 Disposable Foam Knee/Body Strap, 4" x 60" Disposable Poly/Nylon Knee/Body Strap with Metal Ring, 3" x 30" CPE Gown surgical gown-hp-3 Surgical Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-03-19
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-02
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-03-04
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2021-04-16
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-02
QLV	Field Generator Positioning Device	Neurology	Class 1	882.4565	2021-03-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-03-04
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-15
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2021-05-19
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-12-21

Official Correspondent

Sun Chongtao

US Agent Details

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

Related Public Records

Same Entity

Weihai Dishang Medical Technology 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016680721. Last updated year: 2026. Please use registration number 3016680721 when referencing this establishment in official correspondence.