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Lepu Medical Technology (Beijing) Co. Ltd

✓ Record-verifiedregistrations found in 10 marketsUnified social credit code 911100007000084768

This company holds 78 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets.

Registrations by market

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

CNChinaNMPA

78China registrations

Class II 16Class III 62

as of 2026-09-04

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 7Class III 0

plus 12 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 2Class IIa 3Class IIb 2Class III 2

BRBrazilANVISA

46registered devices

Class I 8Class II 38

85 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

13valid device licences

Class II 10Class III 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Business type not stated 1Import 2Manufacturing 1

AUAustraliaTGA ARTG

13active ARTG entries

Class III 8IIa 1IIb 2Class Is (sterile) 2

HKHong KongMDACS

6valid listings

Class II 2Class IV 4

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

33active registrations

Class 2a 5Class 2b 9Class 3 19

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 Union4,367 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States12 registration records, 8 510(k), 0 PMA, 1 excluded

China78 certificates (Class III 62 / II 16 / I 0), as of 2026-09-04

United Kingdom9 confirmed, 0 excluded

Brazil46 confirmed, 1 excluded

Manufacturer names merged into this page: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD · BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD. · LEPU MEDICAL TECHNOLOGY (BEIJING ) CO., LTD. · BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

UK responsible person: NPZ technology Ltd
Unified social credit code: 911100007000084768
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1999-06-11
Registered capital: CNY 1,880,610,488
Paid-in capital: CNY 1,843,424,716
Legal form: Joint-stock limited company (foreign-invested, listed)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2024-11-14
Recognitions: National High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centreTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

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

12011 · K111837

12013 · K123473

32014 · K140768

12015 · K141707

12017 · K172099

12018 · K172331

FDA listed device types

Wire, Guide, Catheter 1Introducer, Catheter 1Wire, Guide, Catheter, Exempt 1Catheters, Transluminal Coronary Angioplasty, Percutaneous 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Syringe, Balloon Inflation, Exempt 1Clamp, Vascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263130521	钴基合金生物可降解涂层雷帕霉素洗脱支架系统	Class III
CN	国械注准20263031774	一次性使用微导管	Class III
CN	国械注准20263031583	血管造影导管	Class III
CN	国械注准20263031191	冠状动脉球囊扩张导管	Class III
UK	17541	Angiopower Inflation Device	Class I
UK	44088	Vesscide Cutting Balloon Dilatation Catheter	Class III
UK	36079	Angioway Y-Hemostasis Valve Set	Class IIa
US	K172331	Type I, Type II, Type III, Type IV	2018-03-02
US	K172099	Shoocin Introducer Kit	2017-10-05
US	K141707	ULTRASKIN HYDROPHILIC GUIDE WIRE	2015-01-21
BR	80102519300	Cateter de Dilatação de Balão para ATP Supercross Pro	Class II
BR	80102519315	Microcateter descartável	Class II
BR	80102519325	Bainha Arterial Descartável PeakSheath Hydrophilic SN 02	Class II