HomeChinaTonglu Qianyan Medtech Co.,Ltd.

Tonglu Qianyan Medtech Co.,Ltd.

China · 杭州
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000017342Unified social credit code 913301223966518352

This company holds 1 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
1China registrations
Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
47UDI-DI device records
Class IIa 31Class IIb 16
USUnited StatesFDA openFDA
7listed device types
Class I 4Class II 3Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
11registered device records
Class IIa 6Class IIb 5
BRBrazilANVISA
27registered devices
Class I 5Class II 22
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
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
5active ARTG entries
IIa 2IIb 3
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 Union47 raw hits, 0 excluded, 47 confirmed
United States10 registration records, 0 510(k), 0 PMA
China1 certificates (Class III 0 / II 1 / I 0), as of 2026-09-04
United Kingdom11 confirmed, 0 excluded
Brazil27 confirmed, 0 excluded
Manufacturer names merged into this page: TONGLU QIANYAN MEDTECH CO.,LTD · TONGLU QIANYAN MEDTECH CO., LTD. · TONGLU QIANYAN MEDTECH CO. LTD. · Tonglu Qianyan Medtch Co., Ltd. · Tonglu Qianyan Medtech Co. Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000017342
EU authorised representative
Eunitor GmbH
UK responsible person
Schultz Medical (UK) Ltd
Unified social credit code
913301223966518352
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
69
Annual revenue
RMB 30–50M

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2014-08-29
Registered capital
CNY 2,000,000
Paid-in capital
CNY 1,800,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2024-05-10
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI 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.

FDA listed device types

Retainer, Surgical 1Instrument, Manual, Surgical, General Use 1Pack, Hot Or Cold, Disposable 1Laparoscopic Accessories, Gynecologic 1Electrosurgical, Cutting & Coagulation & Accessories 1Cannula, Manipulator/Injector, Uterine 1Culdoscope (And Accessories) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20252061184一次性使用内窥镜标本取物袋Class II
EU06937893900626Class IIb
EU06937893903931Class IIa
EU06937893903849Class IIa
EU06937893900640Class IIb
UK48179Bladder EvacuatorClass IIa
UK57944Surgical Instrument ElectrodeClass IIb
UK46678Biopsy NeedleClass IIa
BR80533420114Porta Agulhas Laparoscópico EndomasterClass I
BR80533429036IRRIGADOR MANUAL COM CATETER E VÁLVULA ANTIRRETORNO ENDOMASTERClass II
BR80533429037Morcelador Laparoscópico Descartável EndomasterClass II

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