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Zumax Medical Co.,Ltd.

China · 苏州

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000011126Unified social credit code 91320505771515993L

This company holds 47 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 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

47China registrations

Class I 28Class II 18Class III 1

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 300

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

USUnited StatesFDA openFDA

19listed device types

Class I 13Class II 6Class III 0

plus 20 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 2

BRBrazilANVISA

10registered devices

Class I 10

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 5Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 2Class 2a 2

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 Union963 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States20 registration records, 1 510(k), 0 PMA

China47 certificates (Class III 1 / II 18 / I 28), as of 2026-09-04

United Kingdom2 confirmed, 0 excluded

Brazil10 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: ZUMAX MEDICAL CO, LTD. · ZUMAX MEDICAL CO., LTD. · Zumax Medical Co Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000011126
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Medimap Ltd
Unified social credit code: 91320505771515993L
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2005-04-15
Registered capital: CNY 46,682,000
Paid-in capital: CNY 44,000,000
Legal form: Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-06-25
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI SMEGazelle enterpriseAbove-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

12026 · K252464

FDA listed device types

showing 8 of 19

Transilluminator, Battery-Powered 1Light, Examination, Medical, Battery Powered 1Unit, Suction Operatory 1Loupe, Binocular, Low Power 1Instrument, Hand, Calculus Removal 1Instrument, Microsurgical 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Speculum, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253012603	口腔手术导航设备	Class III
CN	苏械注准20262180522	光学阴道镜	Class II
CN	苏械注准20262061209	手术显微镜	Class II
CN	苏械注准20262060976	手术显微镜	Class II
EU	06945095528791	OMS3500	Class I
EU	06945095528807	OMS2350	Class I
EU	06945095528838	OMS2000	Class I
EU	06945095528852	OMS3200	Class I
UK	10960	colposcope	Class I
UK	35191	surgical microscope	Class I
US	K252464	Surgical Microscope (OMS2360, OMS2380)	2026-04-28
BR	80070210041	OTOSCÓPIO FIBRA ÓPTICA 3.5V MD	Class I
BR	80070210019	FOTÓFORO MD	Class I
BR	80070219007	RETINOSCÓPIO 3,5V MD	Class I
SA	ME0000010176SFDAA00001	Headlight	—
SA	ME0000010176SFDAA00002	Binocular Loupes	—

Zumax Medical 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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