Home›China›Wenzhou Bokang Instruments Co. Ltd.

Wenzhou Bokang Instruments Co. Ltd.

China · Wenzhou Zhejiang · www.bokang.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000021505Unified social credit code 91330303254496528B

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

Registrations by market

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

CNChinaNMPA

9China registrations

Class I 5Class II 4

as of 2026-09-04

EUEuropean UnionEUDAMED

123UDI-DI device records

Class I 111Class IIa 12

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 3Class IIa 4

BRBrazilANVISA

2registered devices

Class I 2

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

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 Union125 raw hits, 2 excluded, 123 confirmed

United States5 registration records, 3 510(k), 0 PMA

China9 certificates (Class III 0 / II 4 / I 5), as of 2026-09-04

United Kingdom7 confirmed, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: Wenzhou Bokang Glasses Manufacture Co.,Ltd · WENZHOU BOKANG INSTRUMENT CO. LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000021505
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91330303254496528B
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1996-07-30
Registered capital: CNY 5,000,000
Paid-in capital: CNY 5,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Instruments and meters manufacturing
Last approval date: 2026-07-08
Recognitions: Micro and small enterpriseInnovative SMEAbove-designated-size industrial enterprise

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

12005 · K043286

12012 · K111141

12018 · K173246

FDA listed device types

Spectacle, Magnifying 1Lens, Spectacle, Non-Custom (Prescription) 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20192070321	上臂式电子血压计	Class II
CN	浙械注准20192070100	血压表	Class II
CN	浙械注准20172070938	无水银血压计	Class II
CN	浙械注准20152070072	红外额温计	Class II
EU	06931038600631	aneroid sphygmomanometer	Class I
EU	06931038600624	aneroid sphygmomanometer	Class I
EU	06931038600617	aneroid sphygmomanometer	Class I
EU	06931038660529	Blood pressure monitor	Class IIa
UK	16156	Aneroid Sphygmomanometer	Class I
UK	16156	Aneroid Sphygmomanometer	Class I
UK	45617	Electronic Sphygmomanometer	Class IIa
US	K173246	ANEROID SPHYGMOMANOMETER	2018-05-30
US	K111141	BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR	2012-02-21
US	K043286	ANEROID SPHYGMOMANOMETER, MODEL BK2002	2005-01-13
BR	80629710003	ESTETOSCÓPIO IAESTETO	Class I
BR	10150470457	Estetoscópio Wiltex	Class I