HomeGermanyrisa GmbH

risa GmbH

Germany · Engen · www.risa-germany.eu
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Australia — 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
0UDI-DI device records
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class IIa 4
BRBrazilANVISA
5registered devices
Class I 3Class II 2
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
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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 Union21 raw hits, 21 excluded, 0 confirmed
United States6 registration records, 0 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: RISA GmbH · RISA GMBH

Regulatory identity

UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Germany
City
Engen
Website
www.risa-germany.eu

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

Screwdriver 1Reamer 1Bit, Drill 1Countersink 1Passer, Wire, Orthopedic 1Blade, Saw, General & Plastic Surgery, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
UK35297Drill Head, front cutting, Ø 10.0 mm for risa medullary reamer changeable head system non sterileClass IIa
UK36249Countersink Ø 10.0 x 185/10 mm,cannulated Ø 2.5 mm | Jacobs-coupling,Scale 10-100 mm,non sterileClass IIa
UK44984´Saw Blade ´´DeSoutter´´ useable length 31mm /width 10,1mm/ thickness 0,3mm / teeth crossed 0,4mmClass IIa
BR10314800167Instrumentais cirurgicos de uso manualClass I
BR10314800169Lâminas -RisaClass II
BR10314800128INSTRUMENTAIS CIRURGICOS - RISAClass II

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