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Sinovation (Beijing) Medical Technology Co.,Ltd.

✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 911101067715865809

This company holds 12 NMPA certificates in China and has registrations in United States, South Korea, Hong Kong — 3 overseas markets.

Registrations by market

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

CNChinaNMPA

12China registrations

Class I 8Class III 4

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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.

United States1 registration records, 2 510(k), 0 PMA

China12 certificates (Class III 4 / II 0 / I 8), as of 2026-09-04

Manufacturer names merged into this page: Sinovation (Beijing) Medical Technology Co., Ltd

Regulatory identity

Unified social credit code: 911101067715865809
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2005-01-26
Registered capital: CNY 3,240,000
Paid-in capital: CNY 3,240,000
Legal form: Limited liability company (wholly corporate-owned)
Industry classification: Technology promotion and application services
Last approval date: 2026-02-04
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEInnovative 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	国械注准20233011148	颅内深部热凝电极	Class III
CN	国械注准20153070705	颅内皮层电极	Class III
CN	国械注准20153070704	软性蝶骨电极	Class III
CN	国械注准20153070702	颅内深部电极	Class III
US	K250363	Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept	2025-11-05
US	K220072	Sinobot X1	2023-06-18

Sinovation (Beijing) Medical Technology 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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