PROMEDON S.A.

Argentina · Cordoba

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 1Class II 20

50 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class III 6

7 including historic records

TWTaiwanTFDA

7valid device licences

Class II 5Class III 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

13active registrations

Class 2b 12Class 3 1

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 States0 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil21 confirmed, 2 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: PROMEDON S.A. · PROMEDON S.A

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110420	OPHIRA MINI SLING SYSTEM	2012-05-08
BR	10306849019	Nefrodrain	Class II
BR	10306840071	CATETER COLETOR DE CÁLCULOS STRATONE	Class II
BR	10306840160	Stratone Tipless VL	Class II
CA	63341	SAFYRE-T AUTOFIXATION SYSTEM	Class III
CA	63342	SAFYRE VS AUTOFIXATION SYSTEM	Class III
CA	77753	ARGUS ADJUSTABLE MALE SLING	Class III

PROMEDON S.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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