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Pentapharm , Ltd.

Switzerland · Aesch

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, South Korea, Australia, Israel — 5 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

5listed device types

Class I 0Class II 5Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States6 registration records, 3 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: PENTAPHARM AG

FDA 510(k) clearances by year

22004 · K042760

12010 · K083842

FDA listed device types

Test, Time, Partial Thromboplastin 1System, Multipurpose For In Vitro Coagulation Studies 1Plasma, Coagulation Control 1Control, Plasma, Abnormal 1Plasma, Control, Normal 1

Market	Identifier	Name	Class / date
US	K083842	ROTEM DELTA THROMBOELASTOMETRY SYSTEM	2010-03-23
US	K042760	PEFAKIT APC-R FACTOR V LEIDEN CONTROLS	2004-12-22
US	K042762	PEFAKIT APC-R FACTOR V LEIDEN	2004-12-22

Pentapharm , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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