HomeChinaShenzhen Envisen Industy.Co., Limited

Shenzhen Envisen Industy.Co., Limited

China · 深圳 · www.envisen.cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000010838Unified social credit code 91440300752517264R

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Taiwan, Singapore, Australia, Israel — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 3Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
161UDI-DI device records
Class I 30Class IIa 91Class IIb 40
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIb 1
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
12active ARTG entries
Class I 4IIa 5IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union161 raw hits, 0 excluded, 161 confirmed
United States1 registration records, 2 510(k), 0 PMA
China12 certificates (Class III 0 / II 9 / I 3), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN ENVISEN INDUSTRY CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000010838
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Neoventa Medical Ltd
Unified social credit code
91440300752517264R
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
158
Annual revenue
RMB 50–100M
Website
www.envisen.cn
Product categories
医用诊察和监护器械呼吸、麻醉和急救器械医用电子

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
2003-09-18
Registered capital
HKD 1,000,000
Paid-in capital
HKD 1,000,000
Legal form
Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification
Instruments and meters manufacturing
Last approval date
2025-08-08
Recognitions
Micro and small enterpriseNational High-Tech Enterprise
Listing
Listed on a regional equity 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 · K103584
12022 · K212945

FDA listed device types

Support, Patient Position 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242071187指套式脉搏血氧仪Class II
CN粤械注准20222070947无菌一次性体温传感器Class II
CN粤械注准20212141847一次性使用无菌测温导尿管Class II
CN粤械注准20182070473重复性使用脉搏血氧饱和度探头Class II
EU06971449610669Breathing CircuitClass IIa
EU06971449610041Breathing CircuitClass IIa
EU06971449611994Pulse OximeterClass IIb
EU06971449611987Pulse OximeterClass IIb
UK37808Reusable SpO2 Finger ClipClass IIb
USK212945Sterile Disposable Temperature Probe2022-03-01
USK103584ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS2011-06-10

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