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Piccolo Medical, Inc.

USA · San Francisco

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

4listed device types

Class I 0Class II 4Class III 0

plus 2 registration records and 4 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 1Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States2 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: PICCOLO MEDICAL

FDA 510(k) clearances by year

12021 · K200037

12024 · K240486

22025 · K252792

FDA listed device types

Electrode, Electrocardiograph 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Saline, Vascular Access Flush 1Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1

Market	Identifier	Name	Class / date
US	K252792	PM2 System with ECGuide Connector	2025-11-17
US	K243484	PM2+ System and SmartPICC Stylet	2025-05-29
US	K240486	PM2 System and ECGuide Connector	2024-09-08

Piccolo Medical, Inc.

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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