HomePoland3M POLAND MANUFACTURING SP. Z O.O

3M POLAND MANUFACTURING SP. Z O.O

Poland · Wroclaw Dolno?L?Skie
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel, Russia — 9 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
4registered devices
Class I 3Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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
Brazil4 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 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 Sp.z.o.o., Stryker Poland Manufacturing Sp. z o.o.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Poland
City
Wroclaw Dolno?L?Skie

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
BR802849302643M MEDIPORE H FITA MÉDICA SUAVEClass I
BR10345160646CLINITEK ADVANTUS ANALYZERClass II
SAME0000001684SFDAA00004Nexcare Happy Kids
SAME0000009307SFDAA00035Nexcare Finger Plasters

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