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Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

China · Hangzhou Zhejiang · www.genesis-ivd.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000013495

This company has registrations in European Union, United States, Brazil, Hong Kong — 4 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

121UDI-DI device records

Class I 15IVD A 20IVD general 80ivd-devices-self-testing 6

USUnited StatesFDA openFDA

5listed device types

Class I 4Class II 1Class III 0

plus 5 registration records and 1 510(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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

IVD B 1IVD C 3

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 Union122 raw hits, 1 excluded, 121 confirmed

United States5 registration records, 1 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD. · HANGZHOU GENESIS BIODETECTION AND BIOCONTROL CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000013495
EU authorised representative: Lotus NL B.V.

FDA 510(k) clearances by year

12023 · K231027

FDA listed device types

Applicator, Absorbent Tipped, Sterile 1Culture Media, Non-Propagating Transport 1Container, Specimen, Sterile 1Culture Media, Non-Selective And Non-Differential 1Reagent, Occult Blood 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16972698603027	Extended ViralTrans	IVD A
EU	16972698602969	BacTrans Swabs	Class I
EU	16972698602983	BacTrans Swabs	Class I
EU	16972698602976	BacTrans Swabs	Class I
US	K231027	KaiBiLi Extended ViralTrans	2023-12-21
BR	82533950005	Swab Ponta Rayon	Class I

Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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