PRIMA Lab SA

Switzerland · Morbio Inferiore · www.primalabsa.ch

✓ Record-verifiedregistrations found in 3 marketsEU SRN CH-MF-000034473

This company has registrations in European Union, United Kingdom, Brazil — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

45UDI-DI device records

IVD B 3IVD C 4IVD general 2ivd-annex-ii-list-a 3ivd-annex-ii-list-b 3ivd-devices-self-testing 30

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

30registered device records

IVD general 6Class C – Self-testing or Near-patient Testing 1IVD Annex II List A 1IVD Annex II List B 1IVD Devices for Self-Testing 21

BRBrazilANVISA

1registered devices

Class II 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 Union202 raw hits, 157 excluded, 45 confirmed

United States0 registration records, 0 510(k), 0 PMA, 6 excluded

United Kingdom30 confirmed, 9 excluded

Brazil1 confirmed, 5 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: PRIMA LAB SA

Regulatory identity

EU manufacturer SRN: CH-MF-000034473
EU authorised representative: QbD RepS BV
UK responsible person: Qarad UK Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07640164860176	Newfoundland Strep A Self-test	ivd-devices-self-testing
EU	D-100082-1ACVH	SPERM TEST	ivd-devices-self-testing
EU	D-80003GC	axaclear early	ivd-devices-self-testing
EU	D-80002GA	Axaclear early	ivd-devices-self-testing
UK	65992	berkeleyhealth Allergy IgE	IVD Devices for Self-Testing
UK	65992	Allergy IgE Test	IVD Devices for Self-Testing
UK	42923	One + Step Amniocheck	IVD Devices for Self-Testing
BR	83019490001	Glutein - Autoteste para rastreio de doença Celíaca	Class II

PRIMA Lab SA

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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