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B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD

China · Dongguan Guangdong

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 11Class II 1Class III 0

plus 15 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 6Class II 1

8 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

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.

United States15 registration records, 0 510(k), 0 PMA, 12 excluded

Brazil7 confirmed, 6 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SHENZHEN LYA SILICONE RUBBER PRODUCTS CO.,LTD · B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD · SHENZHEN KINGOD SILICONE RUBBER PRODUCTS CO.,LTD · DONGGUAN VULCANPRO SILICONE RUBBER INDUSTRIAL CO.,LTD · KINNER SILICONE RUBBER INDÚSTRIA E COMÉRCIO LTDA

FDA listed device types

showing 8 of 12

Prosthesis, Breast, External, No Adhesive 1Aligner, Bracket, Orthodontic 1Applicator, Vaginal 1Container, Specimen, Non-Sterile 1Clamp, Wire, Orthodontic 1Toothbrush, Manual 1Protector, Dental 1Ring, Teething, Non-Fluid Filled 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80280200008	BOLSA DE INFUSÃO - SISTEMA DE PRESSURIZAÇÃO COM INDICADOR DE PRESSÃO P	Class I
BR	80280200004	CIRCUITO PARA VENTILAÇÃO EM SILICONE NÃO ESTÉRIL KINNER	Class I
BR	80280200005	CIRCUITO PARA ANESTESIA EM SILICONE NÃO ESTÉRIL KINNER	Class I

B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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