Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004496829

FEI Number

3004496829

Entity Name

Berpu Medical Technology Co., Ltd.

City/State/Country

WENZHOU Zhejiang, CN

Establishment Address

No.14 Xingji Road, Yongxing Street, Longwan District, WENZHOU Zhejiang 325000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Berpu Medical Technology Co., Ltd. (Owner Number: 9061974)

Owner / Operator Contact Address

No. 14 Xingji Road, Yongxing Street, Longwan Distric, Wenzhou, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213811

PMA Number

N/A

All Registered Proprietary Names

cobas sense venous pipettes Syringe, piston CONTAINER, SPECIMEN, STERILE ONE-CARE pen needle Sterile Dental Needles for Single Use Sterile Irrigation Needle for Single Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2026-02-04
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-03-06
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2022-07-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-01-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-03-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2020-09-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-03-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-04-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Berpu 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3010127792	Sartorius Liquid Handling Oy	Kajaani, Finland Kainuu, FI
3010683392	JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
3023591031	SEQUITUR HEALTH CORP.	Phoenix, AZ, US
3001856801	RITTER GMBH	Schwabmuenchen Bavaria, DE
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004496829. Last updated year: 2026. Please use registration number 3004496829 when referencing this establishment in official correspondence.