HomeGermanyPOLYTECH HEALTH & AESTHETICS GMBH

POLYTECH HEALTH & AESTHETICS GMBH

Germany
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 7 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
8 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2Class III 3IIa 1IIb 3
HKHong KongMDACS
5valid listings
Class III 3Class IV 2
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 1Class 2b 2Class 3 3
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 States0 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 1 excluded
Manufacturer names merged into this page: POLYTECH HEALTH & AESTHETICS GMBH · POLYTECH HEALTH & AESTETHICS

Company information

Country
Germany

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR80526060009POLYTECH Health & Aesthetics Silicone-Gel SheetsClass I
BR80526060002MEDIDOR DE IMPLANTE DE MAMA DE GEL DE SILICONEClass II
BR80526060011Sizer Estéril de Implante Mamamário preenchido de Gel de SiliconeClass II

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