Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010806410

FEI Number

3010806410

Entity Name

CHANGSHU BEYOND MEDICAL DEVICE CO., LTD.

City/State/Country

Changshu Jiangsu, CN

Establishment Address

No. 386 Changkun Road, 215500, Changshu City, Changshu Jiangsu 215500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ChangShu Beyond Medical Device Co., Ltd. (Owner Number: 10046360)

Owner / Operator Contact Address

No. 386 Changkun Road, 215500, Changshu City, Changshu, CN-JS 215500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Protective Eyewear Eye shield goggles safety goggle Beyond urine bags Infant Urine Bags Leg Urine Bags Urine Meter leg urine bag DrainageCatheters Wound Drainage External catheter Urinal beyond wound drainage reservoir wound Drainage reservoir reservoir kit preventive suit Non-Surgical Isolation Gown Isolation Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-10
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2014-03-12
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2017-06-14
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2019-09-25
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-03-12
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2016-09-11
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2014-03-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-10

Official Correspondent

Jianxin Zhu

US Agent Details

Xufeng Chen Email: Ybx99@Yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

ChangShu Beyond Medical Device 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010806410. Last updated year: 2026. Please use registration number 3010806410 when referencing this establishment in official correspondence.