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PROMEPLA S.A.M.

Monaco · Monte Carlo · www.promepla.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN MC-MF-000015769

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 9 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

244UDI-DI device records

Class I 51Class IIa 193

USUnited StatesFDA openFDA

12listed device types

Class I 4Class II 8Class III 0

plus 15 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 9Class IIa 9

BRBrazilANVISA

3registered devices

Class II 3

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

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 1IIa 5Class Is (sterile) 3

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 Union244 raw hits, 0 excluded, 244 confirmed

United States15 registration records, 5 510(k), 0 PMA, 1 excluded

United Kingdom18 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: PROMEPLA S.A.M · PROMEPLA S.A.M. · PROMEPLA S.A.M

Regulatory identity

EU manufacturer SRN: MC-MF-000015769
EU authorised representative: Promepla Group S.à r.l.
UK responsible person: International Associates Limited

FDA 510(k) clearances by year

12012 · K120160

12014 · K140441

12016 · K152278

22018 · K182144

FDA listed device types

showing 8 of 12

Device, Cystometric, Hydraulic 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Tube, Aspirating, Flexible, Connecting 1Injector, Contrast Medium, Automatic 1Lithotriptor, Ultrasonic 1Lithotriptor, Electro-Hydraulic 1Pump, Portable, Aspiration (Manual Or Powered) 1Dislodger, Stone, Flexible 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03700512907138	—	Class I
EU	03700512907121	—	Class I
EU	03700512907114	—	Class I
EU	03700512907107	—	Class I
UK	46553	Gynecology	Class I
UK	45846	Hydrophobic filter	Class I
UK	58977	Infusion - transfusion dialysis	Class IIa
US	K182144	Bi-Flex Evo	2018-09-07
US	K173734	RocaJJ Soft Stents	2018-03-12
US	K152278	ENDOFLOW II - Irrigation, Warming and Suction System	2016-02-09
BR	80120829002	STERIVEIN® SET - SISTEMA DE FORMAÇÃO DE ESPUMA PARA PRODUTO ESCLEROSAN	Class II
BR	81612410008	Conjunto de Tubos EIP 2 para Pinça Irrigada	Class II
BR	81612410009	Conjunto de Tubos EIP 2 para Endoscopia	Class II
CA	102780	TUBING	Class II

PROMEPLA S.A.M.

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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