HomeSwitzerlandSPD SWISS PRECISION DIAGNOSTICS GMBH.

SPD SWISS PRECISION DIAGNOSTICS GMBH.

Switzerland · Petit-Lancy
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 22 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class II 7
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
19active device licences
Class II 19
38 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 2 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
7active registrations
Class 2a 7
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 States22 registration records, 4 510(k), 0 PMA, 2 excluded
Brazil7 confirmed, 0 excluded
Canada19 confirmed, 0 excluded
Manufacturer names merged into this page: SPD SWISS PRECISION DIAGNOSTICS GMBH · SPD SWISS PRECISION DIAGNOSTICS GMBH.

Company information

Country
Switzerland
City
Petit-Lancy

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

12021 · K200913
22022 · K213379
12024 · K240025

FDA listed device types

Kit, Test, Pregnancy, Hcg, Over The Counter 1Radioimmunoassay, Luteinizing Hormone 1Test, Luteinizing Hormone (Lh), Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240025Clearblue® Early Detection Pregnancy Test2024-01-31
USK213379Clearblue ® Early Pregnancy Test2022-09-21
USK210341One Step Pregnancy Test2022-03-10
BR80686360275Clearblue Teste de Gravidez Saiba AntesClass II
BR80686360213Clearblue Teste de Ovulação DigitalClass II
BR80686360214Clearblue Teste de Gravidez Detecção Rápida.Class II
CA2931CLEARBLUE FERTILITY MONITORClass II
CA62820DIGITAL PREGNANCY TESTClass II
CA62821CLEARBLUE PREGNANCY TESTClass II

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