Home›China›Yantai Addcare Bio-Tech Co., Ltd.

Yantai Addcare Bio-Tech Co., Ltd.

China · Yantai Shandong

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 3 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

8listed device types

Class I 8Class II 0Class III 0

plus 8 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 7Class II 2

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

7active registrations

Class 1 1Class 2a 6

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 States8 registration records, 0 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: Yantai Addcare Bio-Tech Co., Ltd. · YANTAI ADDCARE BIO-TECH CO.,LTD.

FDA listed device types

Clinical Sample Concentrator 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Fluorometer, For Clinical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Station, Pipetting And Diluting, For Clinical Use 1Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use 1Bath, Incubators/Water, All 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80102512969	Extrator de Ácido Nucleico totalmente automático - NA4424	Class I
BR	80102512970	Família de Extrator de Ácido Nucleico Totalmente Automatizado	Class I
BR	80102512971	Extrator de Ácido Nucleico totalmente automático - ADC CH196	Class I

Yantai Addcare Bio-Tech Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies