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Hangzhou Bioer Technology Co., Ltd.

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000019512Unified social credit code 913301007399478414

This company holds 38 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Russia — 7 overseas markets.

Registrations by market

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

CNChinaNMPA

38China registrations

Class I 17Class II 5Class III 16

as of 2026-09-04

EUEuropean UnionEUDAMED

254UDI-DI device records

IVD A 231IVD B 9IVD C 8IVD general 6

USUnited StatesFDA openFDA

6listed device types

Class I 4Class II 2Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

4registered device records

IVD general 4

BRBrazilANVISA

29registered devices

Class I 16Class II 13

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 1 4IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 Union258 raw hits, 4 excluded, 254 confirmed

United States6 registration records, 1 510(k), 0 PMA

China38 certificates (Class III 16 / II 5 / I 17), as of 2026-09-04

United Kingdom4 confirmed, 0 excluded

Brazil29 confirmed, 0 excluded

Manufacturer names merged into this page: Hangzhou Bioer Technology Co., Ltd · HANGZHOU BIOER TECHNOLOGY CO., LTD. · BIOER TECHNOLOGY

Regulatory identity

EU manufacturer SRN: CN-MF-000019512
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 913301007399478414
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-06-28
Registered capital: CNY 63,317,143
Paid-in capital: CNY 63,317,143
Legal form: Joint-stock limited company (unlisted)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2024-10-25
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI SMERecognised enterprise technology centreAbove-designated-size industrial enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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

12024 · K222771

FDA listed device types

Real Time Nucleic Acid Amplification System 1Microbial Nucleic Acid Storage And Stabilization Device 1Clinical Sample Concentrator 1Thermocycler, Generic 1Culture Media, Non-Selective And Non-Differential 1Block, Heating 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263221267	全自动核酸提纯及实时荧光PCR分析系统	Class III
CN	国械注准20253400948	甲型/乙型流感病毒核酸检测试剂盒（荧光PCR法）	Class III
CN	国械注准20253400296	呼吸道合胞病毒A型/B型核酸检测试剂盒（PCR-荧光探针法）	Class III
CN	国械注准20253221022	全自动核酸检测分析仪	Class III
EU	06973843227795	HPV Genotyping Real-Time PCR Kit (Fluorescent PCR)	IVD C
EU	06973843227863	HPV Genotyping Real-Time PCR Kit (Fluorescent PCR)	IVD C
EU	06973843227177	MagaBio FFPE Tissue Genomic DNA Purification Kit	IVD A
EU	06973843223742	MagaBio plus Whole Blood Genomic DNA Purification Kit	IVD A
UK	63232	Sample Preservative Fluid	IVD general
UK	52521	MagaBio plus Virus DNA/RNA Purification Kit ?	IVD general
UK	60737	Automated Nucleic Acid Purification System	IVD general
US	K222771	Sample Preservative Fluid	2024-06-26
BR	80117581210	Kit MagaBio plus de Purificação de DNA/RNA de Vírus III	Class I
BR	81128690033	FAMÍLIA SISTEMA AUTOMATIZADO DE EXTRAÇÃO E PURIFICAÇÃO DE ÁCIDOS NUCLE	Class I
BR	81128690034	SISTEMA AUTOMATIZADO DE EXTRAÇÃO E PURIFICAÇÃO DE ÁCIDOS NUCLEICOS (DN	Class I

Hangzhou Bioer Technology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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