HomeChinaDALIAN LATEX CO.,LTD

DALIAN LATEX CO.,LTD

China · 大连
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 912102001185168110

This company holds 9 NMPA certificates in China and has registrations in United States, Brazil — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class I 4Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
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 Union285 raw hits, 285 excluded, 0 confirmed
United States1 registration records, 0 510(k), 0 PMA, 15 excluded
China9 certificates (Class III 0 / II 5 / I 4), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil1 confirmed, 9 excluded
Manufacturer names merged into this page: DALIAN LATEX CO LTD · DALIAN LATEX CO. LTD.

Regulatory identity

Unified social credit code
912102001185168110
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
174
Annual revenue
RMB 50–100M
Product categories
注输、护理和防护器械

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
1975-05-01
Registered capital
CNY 16,343,959
Paid-in capital
CNY 16,343,959
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Rubber and plastic products
Last approval date
2024-10-31
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseNational SRDI "Little Giant"

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 listed device types

Condom 1

Registration details (sample)

MarketIdentifierNameClass / date
CN辽械注准20232140011一次性使用非灭菌橡胶外科手套Class II
CN辽械注准20172180019天然橡胶胶乳男用避孕套Class II
CN辽械注准20162180123天然橡胶胶乳男用避孕套Class II
CN辽械注准20162140210一次性使用医用橡胶检查手套Class II
BR80589510017Luvas de Látex QUALY com póClass I

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