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SHANGHAI XIN CHANG MEMORY ALLOY TECHNOLOGY CO.,LTD.

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000008245Unified social credit code 913101096317839968

This company holds 7 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil — 3 overseas markets.

Registrations by market

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

CNChinaNMPA

7China registrations

Class I 4Class II 1Class III 2

as of 2026-09-04

EUEuropean UnionEUDAMED

14UDI-DI device records

Class III 14

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class III 6

BRBrazilANVISA

0registered devices

7 including historic records

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

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

European Union22 raw hits, 8 excluded, 14 confirmed

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

China7 certificates (Class III 2 / II 1 / I 4), as of 2026-09-04

United Kingdom6 confirmed, 2 excluded

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: SHANGAI SHAPE MEMORY ALLOY CO. LTDA. · SHANGHAI SHAPE MEMORY ALLOY CO., LTD. · SHANGHAI SHAPE MEMORY ALLOY CO, LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000008245
EU authorised representative: Lepu Medical (Europe) Cooperatief U.A.
UK responsible person: NPZ technology Ltd
Unified social credit code: 913101096317839968
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-12-25
Registered capital: CNY 10,000,000
Paid-in capital: CNY 10,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Professional technical services
Last approval date: 2026-03-04
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SME

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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20163132503	形状记忆环抱接骨板	Class III
CN	国械注准20163132502	形状记忆双向张力钩	Class III
CN	沪械注准20242040453	一次性使用无菌磨头	Class II
CN	沪浦械备20240040	胸部固定板	Class I
EU	06933052358147	MemoPart™	Class III
EU	06933052358123	MemoPart™	Class III
EU	06933052358109	MemoPart™	Class III
EU	06933052358093	MemoPart™	Class III
UK	45418	MemoPartTM Atrial Septal Defect (ASD) Occluder	Class III
UK	45418	MemoPartTM Atrial Septal Defect (ASD) Occluder	Class III
UK	45419	MemoPartTM Occluder Delivery System	Class III

SHANGHAI XIN CHANG MEMORY ALLOY TECHNOLOGY CO.,LTD.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

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