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Dongguan ZSR Biomedical Technology Company Limited

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000016828Unified social credit code 914419000735425569

This company holds 27 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

27China registrations

Class I 11Class II 16

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 4Class IIa 296

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 1Class IIa 8

BRBrazilANVISA

1registered devices

Class II 1

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

1active device licences

Class II 1

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union328 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States2 registration records, 2 510(k), 0 PMA

China27 certificates (Class III 0 / II 16 / I 11), as of 2026-09-04

United Kingdom9 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED · DONGGUAN ZSR BIOMEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000016828
EU authorised representative: Caretechion GmbH
UK responsible person: The Haemorrhoid Centre Ltd (trading as The Halo Company)
Unified social credit code: 914419000735425569
Exhibition record: CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2013-07-25
Registered capital: CNY 10,000,000
Paid-in capital: CNY 5,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Other manufacturing
Last approval date: 2019-10-16
Recognitions: Micro and small enterpriseInnovative SME

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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20252060643	内窥镜冲洗吸引系统	Class II
CN	粤械注准20252020427	一次性使用输尿管导引鞘	Class II
CN	粤械注准20232030248	微创扩张引流套件	Class II
CN	粤械注准20222140786	输尿管支架套装	Class II
EU	06936345100003	Tubing Set	Class IIa
EU	06936345110750	Irrigation and Suction Accessories (IRP Wire)	Class I
EU	06936345110682	Irrigation and Suction Accessories (Suction Tube (Machine))	Class I
EU	06936345110675	i-MIMERsys Irrigation and Suction Pump(Disposable Irrigation Tube(3-way))	Class IIa
UK	64309	Ureteral Guide Sheath	Class IIa
UK	63228	Disposable Circumcision Anastomat	Class IIa
UK	47140	Electronic Endoscope Imaging Processor	Class I
US	K243155	Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)	2025-02-11
US	K241181	Disposable Ureteral Guide Sheath	2024-08-02
BR	81772710001	Dispositivo Descartável para Circuncisão Anastomat	Class II
CA	108637	DISPOSABLE CIRCUMCISION ANASTOMAT	Class II

Dongguan ZSR Biomedical Technology Company Limited

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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