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HERSILL, S.L.

Spain · Mostoles (Madrid) · www.hersill.com

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Israel — 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

0UDI-DI device records

USUnited StatesFDA openFDA

8listed device types

Class I 5Class II 3Class III 0

plus 10 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

15registered device records

Class I 4Class IIa 9Class IIb 1System or Procedure Pack 1

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 3IIb 2

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 States10 registration records, 2 510(k), 0 PMA

United Kingdom15 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: HERSILL, S.L. · HERSILL, S. L. · HERSILL S.L

Regulatory identity

UK responsible person: CMC Medical Devices LTD

FDA 510(k) clearances by year

22010 · K094003

FDA listed device types

Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1Regulator, Pressure, Gas Cylinder 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge 1Humidifier, Non-Direct Patient Interface (Home-Use) 1Bottle, Collection, Breathing System (Calibrated) 1Pump, Portable, Aspiration (Manual Or Powered) 1Regulator, Vacuum 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	47366	V7 / Care-e-vac	Class IIa
UK	47366	V7 / Care-e-vac	Class IIa
UK	47366	V7 / Care-e-vac	Class I
US	K094003	REVIVATOR	2010-09-17
US	K093241	V7 PORTABLE SUCTION UNITS	2010-04-27
BR	80443690009	vacup pro. vacup elite. pistola manual	Class I
SA	ME0000005444SFDAA00010	Patient circuit Y-piece, silicone	—
SA	ME0000005444SFDAA00011	CABS manual ventilation circuit- GENESIS	—

HERSILL, S.L.

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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