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SAPI MED S.p.A.

Italy · Alessandria

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

7listed device types

Class I 3Class II 4Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class 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

0active device licences

5 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States7 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: SAPI MED S.P.A · SAPI MED S.P.A. · SAPI MED S.p.A.

FDA listed device types

Ligator, Hemorrhoidal 1Led Light Source 1Anoscope And Accessories 1Sigmoidoscope, Rigid, Non-Electrical 1Retractor, Non-Self-Retaining 1Accessories, Photographic, For Endoscope (Exclude Light Sources) 1Dilator, Rectal 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10209780087	Dilatador anal Dilatan	Class I
BR	10209780072	ANUSCÓPIO PARA DIAGNÓSTICO PROCTOLÓGICO SAPIMED	Class II
BR	10209789004	DRENO PARA FÍSTULA ANAL ANTROSOND	Class II

SAPI MED S.p.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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