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Beijing Fule Science & Technology Development Company

China · 北京

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000006511Unified social credit code 91110117102618418H

This company holds 88 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Taiwan, Australia, Russia — 7 overseas markets.

Registrations by market

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

CNChinaNMPA

88China registrations

Class I 24Class II 18Class III 46

as of 2026-09-04

EUEuropean UnionEUDAMED

88UDI-DI device records

Class I 85Class IIb 3

USUnited StatesFDA openFDA

31listed device types

Class I 31Class II 0Class III 0

plus 31 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

10registered devices

Class I 10

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

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 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 Union88 raw hits, 0 excluded, 88 confirmed

United States31 registration records, 3 510(k), 0 PMA

China88 certificates (Class III 46 / II 18 / I 24), as of 2026-09-04

Brazil10 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. · BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD · Beijing Fule Science & Technology Development Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000006511
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code: 91110117102618418H
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1996-06-28
Registered capital: CNY 100,000,000
Paid-in capital: CNY 100,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-01-30
Recognitions: National High-Tech EnterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centre

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

12025 · K252730

22026 · K253155

FDA listed device types

showing 8 of 31

Template 1Hook, Bone 1Scissors, Orthopedic, Surgical 1Spinal Channeling Instrument, Vertebroplasty 1Handle, Scalpel 1Impactor 1Pliers, Surgical 1Reamer 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263131787	全缝线锚钉	Class III
CN	国械注准20263130815	骨盆内固定系统	Class III
CN	国械注准20263130692	自稳型椎间融合器	Class III
CN	国械注准20263130585	距下关节稳定器	Class III
EU	06936745175885	Curette (Antecurvature）	Class I
EU	06942072973827	Brokeback Device (Ⅴ)	Class I
EU	06942072973810	Sleeve (Ⅵ)	Class I
EU	06936745127983	Bone Hook (Ⅱ)	Class I
US	K253155	Fule Metallic Lockable Intramedullary Nail Systems	2026-06-17
US	K253151	Fule Interbody Fusion Cage System	2026-06-15
US	K252730	Fule Spinal Fixation System	2025-10-24
BR	80868230010	421-Broken Screw Removal Kit	Class I
BR	80868230007	414-003 - ETN Instrument Set	Class I
BR	80868230008	425-002 - PFNA Instrument Set	Class I
SA	ME0000002476SFDAA00169	Connecting Rod	—

Beijing Fule Science & Technology Development Company

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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