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Beijing ZKSK Technology Co., Ltd.

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000010403Unified social credit code 91110106684397431L

This company holds 32 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, South Korea, Australia, Israel, Russia — 10 overseas markets.

Registrations by market

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

CNChinaNMPA

32China registrations

Class I 3Class II 19Class III 10

as of 2026-09-04

EUEuropean UnionEUDAMED

109UDI-DI device records

Class I 3Class IIa 40Class IIb 66

USUnited StatesFDA openFDA

38listed device types

Class I 24Class II 12Class III 0unclassified 2

plus 38 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIa 4

BRBrazilANVISA

25registered devices

Class I 3Class II 22

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

4active ARTG entries

IIa 3IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 4Class 2b 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 Union109 raw hits, 0 excluded, 109 confirmed

United States38 registration records, 6 510(k), 0 PMA

China32 certificates (Class III 10 / II 19 / I 3), as of 2026-09-04

United Kingdom4 confirmed, 0 excluded

Brazil25 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: BEIJING ZKSK TECHNOLOGY CO., LTD. · Beijing ZKSK Technology Co., Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000010403
EU authorised representative: MedPath GmbH
UK responsible person: MedPath Limited
Unified social credit code: 91110106684397431L
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2008-12-24
Registered capital: CNY 10,526,700
Paid-in capital: CNY 10,526,700
Legal form: Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-05-27
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the NEEQ

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

42022 · K213217

12023 · K231721

12025 · K242192

FDA listed device types

showing 8 of 38

Ligator, Esophageal 1Endoscopic Injection Needle, Gastroenterology-Urology 1Forceps, Biopsy, Electric 1Endoscopic Guidewire, Gastroenterology-Urology 1Respirator, Surgical 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Snare, Flexible 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263141493	一次性使用加温管路	Class III
CN	国械注准20253011703	一次性使用等离子手术电极	Class III
CN	国械注准20243011706	一次性使用乳头括约肌切开刀	Class III
CN	国械注准20223101628	一次性使用血液灌流器	Class III
EU	06934415022118	Disposable Hot Biopsy Forceps	Class IIb
EU	06934415088688	Disposable Pulse Lavage	Class IIa
EU	06934415066822	Disposable Electrosurgical Knife	Class IIb
EU	06934415022293	Disposable Hot Biopsy Forceps	Class IIb
UK	35419	Silicone Gastrostomy Tube	Class IIa
UK	64464	Endoscopic Gastrostomy (PEG) KIT	Class IIa
UK	46680	Multi-Band Ligator	Class IIa
US	K242192	Disposable Sphincterotome	2025-02-06
US	K231721	Disposable Hot Biopsy Forceps	2023-12-14
US	K213217	Disposable hemoclip	2022-11-14
BR	82523860020	MIni Kit para Ligadura	Class I
BR	10289689050	Sonda de gastrostomia para nutrição enteral com balão e fixador Medika	Class II
BR	10289689068	Sonda para nutrição enteral em silicone baixo perfil por gastrostomia	Class II
SA	ME0000006455SFDAA00003	Medical Face Shield	—
SA	ME0000006455SFDAA00004	Medical Isolation Goggles	—