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Home›Poland›Stryker Poland Manufacturing Sp. z o.o.

Stryker Poland Manufacturing Sp. z o.o.

Poland · Skawina Ma?Opolskie
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 5 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
126listed device types
Class I 44Class II 77Class III 5
plus 165 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 2Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
2GMP quality-system certificates
Import 2
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.

United States165 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 1 excluded
Saudi Arabia1 confirmed, 1 excluded
Manufacturer names merged into this page: ESSITY OPERATION POLAND Sp.Z o. o. · Stryker Poland Manufacturing Sp. z o.o. · AMETEK Poland sp. z o.o. · STERIPACK MEDICAL POLAND SP. Z O.O. · STERIPACK MEDICAL POLAND SP. Z O.O. ALSO REGISTERED AS S.M.P. SP.Z O.O · GETINGE IC PRODUCTION POLAND SP. Z.O.O.
Same-named companies — This database also contains companies with near-identical names: 3M POLAND MANUFACTURING SP. Z O.O, 3M Poland Sp.z.o.o.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Poland
City
Skawina Ma?Opolskie

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 126
Motor, Surgical Instrument, Ac-Powered 1Instrument, Ent Manual Surgical 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Face Plate Hearing Aid 1Recorder, Paper Chart 1Lift, Patient, Non-Ac-Powered 1Refractometer For Clinical Use 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10356029009A-Zoft Material de Impressão à base de siliconeClass I
BR10345160646CLINITEK ADVANTUS ANALYZERClass II
BR80284930302COBAN LF CORTE MANUALClass I
SAME0000009307SFDAA00035Nexcare Finger Plasters—

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