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SP Medical A/S

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Australia, Israel — 6 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

67listed device types

Class I 29Class II 36Class III 2

plus 75 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 2Class III 1

BRBrazilANVISA

22registered devices

Class II 22

25 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class III 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union179,372 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States75 registration records, 2 510(k), 0 PMA, 61 excluded

United Kingdom3 confirmed, 482 excluded

Brazil22 confirmed, 36 excluded

Saudi Arabia0 confirmed, 34 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: STERIPACK MEDICAL POLAND SP. Z O.O. · METIER MEDICAL SP. Z O.O. · LiNA Medical Polska sp. z o.o · BESTER MEDICAL SYSTEM SP. Z O. O. · FERROSAN MEDICAL DEVICES SP. Z.O.O. · STERIPACK MEDICAL POLAND SP. Z O.O. ALSO REGISTERED AS S.M.P. SP.Z O.O

Regulatory identity

UK responsible person: Advena Ltd

FDA 510(k) clearances by year

12017 · K171193

12026 · K253667

FDA listed device types

showing 8 of 67

Motor, Surgical Instrument, Ac-Powered 1Template 1Forceps 1Evacuator, Bladder, Manually Operated 1Fluid Drainage Tray 1Gauge, Depth 1Supplies, Blood-Bank 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	35094	Accoat Guide Wires	Class III
UK	46691	Accoat Standard Guide Wire	Class IIa
UK	58115	Accoat Standard Guide Wire	Class IIa
US	K253667	Accoat Guide Wire	2026-07-14
US	K171193	Certa Catheter	2017-12-18
BR	81231550015	Fio Guia Hidrofílico Accoat	Class II
BR	81231550017	Fio Guia Teflonado Accoat	Class II
BR	80152120013	FIO GUIA PTFE ACCOAT	Class II

SP Medical A/S

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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