HomeThailandThai Nippon Rubber Industry PLC

Thai Nippon Rubber Industry PLC

Thailand · Bangkok · www.tnrcondom.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN TH-MF-000012641

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 10 overseas markets. EU UDI-DI records ≥92, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
≥92UDI-DI device records
Class I 5Class IIb 87
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 16 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 3Class IIb 4
BRBrazilANVISA
2registered devices
Class II 2
15 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
26valid device licences
Class II 26
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 2b 5
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 Union2,598 raw hits, 208 excluded, 92 confirmed. Large result set — only the first 300 verified
United States16 registration records, 12 510(k), 0 PMA, 3 excluded
United Kingdom7 confirmed, 9 excluded
Brazil2 confirmed, 2 excluded
Manufacturer names merged into this page: THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED · THAI NIPPON RUBBER INDUSTRY CO. LTD. · THAI NIPPON RUBBER INDUSTRY PUBLIC CO., LTD · THAI NIPPON RUBBER INDUSTRY CO., LTD · Thai Nippon Rubber Industry Public Company Limited (PCL)

Regulatory identity

EU manufacturer SRN
TH-MF-000012641
EU authorised representative
MDSS GmbH
UK responsible person
Obelis UK Ltd

Company information

Country
Thailand
City
Bangkok
Website
www.tnrcondom.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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.

FDA 510(k) clearances by year

22000
12001
12003
12009
12015
12018
12019
32021
12022

FDA listed device types

Lubricant, Personal 1Condom With Nonoxynol-9 1Condom 1

Registration details (sample)

MarketIdentifierNameClass / date
EU18852961030188PAMITEX - PLPSOClass IIb
EU18852961029007PAMITEX - PLPBClass IIb
EU18859705102873SAMMAR Powder-Free White Latex Examination Gloves Size XSClass I
EU18859705102910SAMMAR Powder-Free White Latex Examination Gloves Size XLClass I
UK45138EXS Air ThinClass IIb
UK45138EIS Standard CondomClass IIb
UK45138CONFIDOMSClass IIb
USK220273Onetouch Non-paraben Lubricant Gel2022-10-21
USK210095Playboy Premium Silicone Lubricant2021-11-23
USK211450Playboy 3 Contour Condom2021-09-30
BR10438410006SEXY GEL LUBRIFICANTE INTIMOClass II
BR10339360017KS GEL DUE LUBRIFICANTE ÍNTIMOClass II

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