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XIAMEN CHENGLI MEDICAL EQUIPMENT CO.,LTD

✓ Record-verifiedregistrations found in 5 marketsUnified social credit code 913502117692574389

This company holds 10 NMPA certificates in China and has registrations in United States, Brazil, Taiwan, Australia — 4 overseas markets.

Registrations by market

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

CNChinaNMPA

10China registrations

Class I 10

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

13listed device types

Class I 12Class II 1Class III 0

plus 13 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

7registered devices

Class I 7

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

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 States13 registration records, 0 510(k), 0 PMA

China10 certificates (Class III 0 / II 0 / I 10), as of 2026-09-04

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: XIAMEN CHENGLI MEDICAL EQUIPMENT CO., LTD. · XIAMEN CHENGLI MEDICAL EQUIPMENT CO., LTD

Regulatory identity

Unified social credit code: 913502117692574389
Exhibition record: Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2004-12-28
Registered capital: CNY 11,000,000
Paid-in capital: CNY 11,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2021-03-15
Recognitions: Micro and small enterpriseNational High-Tech 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 listed device types

showing 8 of 13

Orthosis, Limb Brace 1Joint, Knee, External Brace 1Orthosis, Truncal/Orthosis, Limb 1Orthosis, Abdominal 1Accessory, Surgical Apparel 1Shoe, Cast 1Splint, Hand, And Components 1Joint, Ankle, External Brace 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	闽厦械备20200293号	腕关节固定器	Class I
CN	闽厦械备20200292号	手指固定器	Class I
CN	闽厦械备20200291号	肘部固定器	Class I
CN	闽厦械备20200087号	隔离衣	Class I
BR	82411060005	Órteses para membros inferiores	Class I
BR	82411060006	Colete TLSO	Class I
BR	82411060009	Colete ortopédico	Class I

XIAMEN CHENGLI MEDICAL EQUIPMENT CO.,LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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