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ALTON(shanghai)medical Instruments Co.,Ltd

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000012832Unified social credit code 91310106771478053L

This company holds 61 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥125, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

61China registrations

Class I 10Class II 41Class III 10

as of 2026-09-04

EUEuropean UnionEUDAMED

≥125UDI-DI device records

Class I 125

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

USUnited StatesFDA openFDA

20listed device types

Class I 6Class II 14Class III 0

plus 18 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

56registered device records

Class I 25Class IIa 25Class IIb 5Custom-made - Class I 1

BRBrazilANVISA

21registered devices

Class I 7Class II 14

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

17active ARTG entries

Class I 7IIa 7IIb 2Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 8Class 2b 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 Union4,965 raw hits, 175 excluded, 125 confirmed. Large result set — only the first 300 verified

United States18 registration records, 6 510(k), 0 PMA, 2 excluded

China61 certificates (Class III 10 / II 41 / I 10), as of 2026-09-04

United Kingdom56 confirmed, 4 excluded

Brazil21 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD · ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD · ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000012832
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Atlantic Bridge Limited
Unified social credit code: 91310106771478053L
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2005-01-26
Registered capital: CNY 20,000,000
Paid-in capital: CNY 1,900,000
Legal form: Limited liability company (Sino-foreign joint venture)
Industry classification: Wholesale trade
Last approval date: 2026-07-13
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centreInnovative 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.

FDA 510(k) clearances by year

12023 · K230925

22024 · K241285

32025 · K243039

FDA listed device types

showing 8 of 20

Ligator, Esophageal 1Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Guidewire, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Colonoscope And Accessories, Flexible/Rigid 1Stent, Ureteral 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Ligator, Hemorrhoidal 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253011699	一次性使用黏膜切开刀	Class III
CN	国械注准20253011402	一次性使用热活检钳	Class III
CN	国械注准20233140053	一次性内镜注射针	Class III
CN	国械注准20223021492	夹子装置	Class III
EU	06942127868955	Disposable Grasping Forceps	Class I
EU	06942127868382	Disposable Grasping Forceps	Class I
EU	06942127868375	Disposable Grasping Forceps	Class I
EU	06942127868368	Disposable Grasping Forceps	Class I
UK	10696	Nasal Biliary Drainage Catheter	Class I
UK	10696	Nasal Biliary Drainage Catheter	Class I
UK	46452	Retrieval Basket (Basket with Tip Type, Nitinol / Stainless Steel)	Class I
US	K243039	Ureteral Stents (AF-D series)	2025-06-18
US	K242635	Endoscopic Distal Attachment (AF-D series)	2025-05-30
US	K241679	Disposable Cytology Brush (AF series)	2025-03-04
BR	81845099018	PINÇA PARA BIOPSIA FLEXIVEL REUTILIZAVEL STEEL ABART	Class II
BR	81845099019	PINÇA PARA BIOPSIA FLEXIVEL REUTILIZAVEL PSF ABART	Class II
BR	81845099020	Pinça Para Biópsia Endoscópica Flexível Descartável ABART	Class II
SA	ME0000000368SFDAA00006	Brush	—