HomeChinaShenzhen XpectVision Technology Co.,Ltd

Shenzhen XpectVision Technology Co.,Ltd

China · 深圳 · www.xpectvision.com.cn
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000021307Unified social credit code 91440300329532213L

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Israel — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 1Class II 9
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
Class I 1Class IIa 1
USUnited StatesFDA openFDA
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 1Class IIa 1
BRBrazilANVISA
1registered devices
Class II 1
2 including historic records
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
2registrations
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 Union2 raw hits, 0 excluded, 2 confirmed
United States4 registration records, 2 510(k), 0 PMA
China10 certificates (Class III 0 / II 9 / I 1), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN XPECTVISION TECHNOLOGY CO., LTD. · SHENZHEN XPECTVISION TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000021307
EU authorised representative
Wellkang Ltd
UK responsible person
Wellkang Ltd
Unified social credit code
91440300329532213L
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
106
Annual revenue
under RMB 5M
Website
www.xpectvision.com.cn
Product categories
医用成像器械健康管理

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
2015-01-28
Registered capital
CNY 101,243,285
Paid-in capital
CNY 10,650,030
Legal form
Limited liability company (HK/Macao/Taiwan invested, not wholly owned, not wholly owned)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-04-16
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative SME

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

12022 · K220277
12024 · K233914

FDA listed device types

System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1Chair, Dental, Without Operative Unit 1Holder, Film, X-Ray 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252060109数字化乳腺X射线系统Class II
CN粤械注准20242210073医学影像存储与传输系统软件Class II
CN粤械注准20232061913口腔内数字化X射线成像系统Class II
CN粤械注准20232061911口腔内数字化X射线成像系统Class II
EU06972259246055Intraoral Digital Impression InstrumentClass I
EU06972259246024Digital Intraoral X-ray SensorClass IIa
UK44905Digital Intraoral X-ray SensorClass IIa
UK63669Intraoral Digital Impression InstrumentClass I
USK233914XVbeam20002024-02-08
USK220277Digital Intraoral X-ray Sensor2022-02-17
BR80117589079Digital intraoral X-ray SensorClass II

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