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Berpu Medical Technology Co., Ltd.

China · Wenzhou Zhejiang · www.berpu.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000012430Unified social credit code 91330303717609518J

This company holds 15 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 11 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

15China registrations

Class II 3Class III 12

as of 2026-09-04

EUEuropean UnionEUDAMED

300UDI-DI device records

Class I 72Class IIa 227IVD A 1

USUnited StatesFDA openFDA

7listed device types

Class I 4Class II 3Class III 0

plus 17 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

31registered device records

Class I 5Class IIa 21IVD A 5

BRBrazilANVISA

38registered devices

Class I 2Class II 36

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 4Class Is (sterile) 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

7active registrations

Class 2a 7

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union300 raw hits, 0 excluded, 300 confirmed

United States17 registration records, 9 510(k), 0 PMA

China15 certificates (Class III 12 / II 3 / I 0), as of 2026-09-04

United Kingdom31 confirmed, 0 excluded

Brazil38 confirmed, 0 excluded

Manufacturer names merged into this page: Berpu Medical Technology Co., Ltd. · BERPU MEDICAL TECHNOLOGY CO., LTD. · BERPU MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000012430
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91330303717609518J
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-09-06
Registered capital: CNY 63,000,000
Paid-in capital: CNY 63,000,000
Legal form: Joint-stock limited company (unlisted)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-03-18
Recognitions: National High-Tech EnterpriseSRDI SMEAbove-designated-size industrial enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12016

12018 · K180417

12019 · K181447

52022 · K221045

12024 · K232165

FDA listed device types

Syringe, Antistick 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1Container, Specimen, Sterile 1Needle, Dental 1Micro Pipette 1Needle, Aspiration And Injection, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263140476	一次性使用正压无针输液接头	Class III
CN	国械注准20253142641	一次性使用防针刺注射笔用针头	Class III
CN	国械注准20233141937	一次性使用注射笔用针头	Class III
CN	国械注准20233141656	一次性使用无菌注射针	Class III
EU	06949236214512	Sterile Insulin pen needles for Single Use	Class IIa
EU	06949236221619	Sterile Dental Needles for Single Use	Class IIa
EU	06949236221633	Sterile Dental Needles for Single Use	Class IIa
EU	06949236221626	Sterile Dental Needles for Single Use	Class IIa
UK	44127	STERILE SAFETY INSULIN PEN NEEDLES FOR SINGLE USE	Class IIa
UK	44127	STERILE INSULIN PEN NEEDLES FOR SINGLE USE	Class IIa
UK	44127	SAFETY INSULIN NEEDLE FOR SINGLE USE	Class IIa
US	K232165	Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles	2024-02-01
US	K221045	Insulin Syringes without needle	2022-11-03
US	K220061	Safety Insulin Syringes	2022-08-23
BR	81628889008	Agulha múltipla com dispositivo de segurança para coleta de sangue a v	Class II
BR	82944399008	Agulha para Coleta Múltipla a Vácuo com Dispositivo de Segurança	Class II
BR	82944399009	Scalp para Coleta Múltipla a Vácuo Simples	Class II