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AUG MEDICAL SP. Z O.O.

Poland · Warsaw · www.augmedicalgroup.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN PL-MF-000019086

This company has registrations in European Union, United Kingdom, Saudi Arabia — 3 overseas markets. EU UDI-DI records ≥265, the first 300 verified individually. 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

≥265UDI-DI device records

Class I 265

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

15registered device records

Class I 15

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

4registered 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

pendingnot queried

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.

European Union906 raw hits, 35 excluded, 265 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom15 confirmed, 5 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: AUG MEDICAL LLC · AUG Medical LLC

Regulatory identity

EU manufacturer SRN: PL-MF-000019086
UK responsible person: IBC GB-UK LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05904507279059	Manual Resuscitator	Class I
EU	05904507279042	Manual Resuscitator	Class I
EU	05904507279035	Manual Resuscitator	Class I
EU	05904507279028	Manual Resuscitator	Class I
UK	31264	Magill's Forceps	Class I
UK	18021	Dermatoscope, optical	Class I
UK	46786	Direct ophthalmoscope	Class I
SA	ME0000017032SFDAA00001	VIDEO LARYNGOSCOPE	—
SA	ME0000013217SFDAA00015	Exlite	—

AUG MEDICAL SP. Z O.O.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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