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SteriPack Sp.z.o.o./s.z.o.o.

Poland · Jelcz-Laskowice · www.ensera.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN PL-PR-000010981

This company has registrations in European Union, United States, United Kingdom, Canada — 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

1UDI-DI device records

Class IIa 1

USUnited StatesFDA openFDA

20listed device types

Class I 6Class II 12Class III 2

plus 19 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

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

1 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

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 Union7 raw hits, 6 excluded, 1 confirmed

United States19 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom1 confirmed, 0 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: STERIPACK MEDICAL POLAND SP. Z O.O. · STERIPACK MEDICAL POLAND SP. Z O.O. ALSO REGISTERED AS S.M.P. SP.Z O.O

Regulatory identity

EU manufacturer SRN: PL-PR-000010981
UK responsible person: Emergo Consulting (UK) Limited

FDA listed device types

showing 8 of 20

Motor, Surgical Instrument, Ac-Powered 1Bit, Drill 1Guide, Needle, Surgical 1Orthopedic Manual Surgical Instrument 1Applicator, Absorbent Tipped, Sterile 1Bandage, Elastic 1Electrode, Needle 1Cable, Electrode 1

Market	Identifier	Name	Class / date
EU	05907527942156	Procedure Pack To Aid Infusion	Class IIa
UK	59230	Safety Needle	Class IIa

SteriPack Sp.z.o.o./s.z.o.o.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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