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Runyes Medical Instrument Co., Ltd.

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000014741Unified social credit code 91330205720475127C

This company holds 85 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 overseas markets.

Registrations by market

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

CNChinaNMPA

85China registrations

Class I 3Class II 12Class III 1

as of 2026-09-04

EUEuropean UnionEUDAMED

85UDI-DI device records

Class I 34Class IIa 39Class IIb 12

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

16registered device records

Class I 5Class IIa 9Class IIb 2

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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 3Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Manufacturing 2

AUAustraliaTGA ARTG

13active ARTG entries

Class I 6IIa 5IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 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 Union85 raw hits, 0 excluded, 85 confirmed

United States6 registration records, 2 510(k), 0 PMA

China85 certificates (Class III 1 / II 12 / I 3), as of 2026-09-04

United Kingdom16 confirmed, 0 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: Ningbo Runyes Medical Instrument Co., Ltd. · NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000014741
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Simmo Compressors Ltd
Unified social credit code: 91330205720475127C
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-05-25
Registered capital: CNY 50,000,000
Paid-in capital: CNY 50,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-05-09
Recognitions: National High-Tech EnterpriseTorch Programme 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

12023 · K231449

12026 · K252909

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Intraoral Camera 1System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253061555	口腔颌面锥形束体层摄影设备	Class III
CN	浙械注准20252061368	牙科X射线机	Class II
CN	浙械注准20242171280	连体式牙科治疗设备	Class II
CN	浙械注准20222060040	口腔数字化X射线成像系统	Class II
EU	06974721257118	POCT22	Class IIb
EU	06974721257125	SUPER05	Class IIb
EU	06974721255565	Care-88	Class IIa
EU	06974721258078	ENROLL-03	Class I
UK	38671	Runyes	Class IIa
UK	47144	Integral Dental Unit Chair	Class IIa
UK	34859	Dental Suction Machine	Class I
US	K252909	Diagnostic X-Ray Equipment Model POCT22	2026-02-03
US	K231449	Portable X-ray System Model Ray98(P)	2023-07-13
BR	82499100006	Intraoral Scanner	Class I
BR	82499109001	Pequenos Esterilizadores a Vapor	Class II
BR	82499109003	Scanner de Placas de Imagens (PSP)	Class II
SA	ME0000013359SFDAA00004	Ultrasonic Cleaner	—
SA	ME0000015458SFDAA00001	Intraoral Scanner	—