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Wenzhou Longwan Medical Device Factory

China · Wenzhou Zhejiang · www.taiyu.net

✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000026106

This company holds 3 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

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

CNChinaNMPA

3China registrations

Class I 2Class II 1

as of 2026-09-04

EUEuropean UnionEUDAMED

41UDI-DI device records

Class I 41

USUnited StatesFDA openFDA

11listed device types

Class I 10Class II 1Class III 0

plus 12 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

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 Union41 raw hits, 0 excluded, 41 confirmed

United States12 registration records, 2 510(k), 0 PMA

China3 certificates (Class III 0 / II 1 / I 2), as of 2026-09-04

Manufacturer names merged into this page: WENZHOU LONGWAN MEDICAL DEVICE FACTORY

Regulatory identity

EU manufacturer SRN: CN-MF-000026106
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 1986-10-04
Registered capital: CNY 580,000
Paid-in capital: CNY 580,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2024-07-08
Recognitions: Micro and small 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 510(k) clearances by year

12006 · K060871

12024 · K240165

FDA listed device types

showing 8 of 11

Kit, First Aid, Talking 1Stethoscope, Manual 1Scissors, Medical, Disposable 1Light, Examination, Medical, Battery Powered 1Bottle, Hot/Cold Water 1Hammer, Surgical 1Infusor, Pressure, For I.V. Bags 1Otoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20262070037	血压表	Class II
CN	浙温械备20240032	双用听诊器	Class I
CN	浙温械备20240031	单用听诊器	Class I
EU	06975531370202	Aneroid Sphygmomanometer	Class I
EU	06975531370196	Aneroid Sphygmomanometer	Class I
EU	06975531370189	Aneroid Sphygmomanometer	Class I
EU	06975531370172	Aneroid Sphygmomanometer	Class I
US	K240165	Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer	2024-03-20
US	K060871	AS101, BLOOD PRESSURE CUFF	2006-06-09

Wenzhou Longwan Medical Device Factory

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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