HomeUSATHERMO FISHER SCIENTIFIC (ASHEVILLE) LLC.

THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC.

USA · Marietta
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Hong Kong, 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
7listed device types
Class I 5Class II 2Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 2Class II 8
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
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
3valid listings
Class II 3
ILIsraelAMAR
9registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 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 States11 registration records, 0 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC · THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC. · Thermo Fisher Scientific Asheville, LLC · Thermo Fisher Scientific ( Asheville) LLC

Company information

Country
USA
City
Marietta

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

Refrigerator, Freezer, Blood Storage 1Accessory, Assisted Reproduction 1Freezer 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Anaerobic Box Glove 1Shaker/Stirrer 1Bath, Incubators/Water, All 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10358949006Blast Freezer for Plasma XBF40D SeriesClass II
BR80254180300Família de Freezers Thermo ScientificClass II
BR80254180301Família de Refrigeradores Thermo ScientificClass II
SAME0000000985SFDAA00012Plazma Freezer

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