HomeUSAMVE BIOLOGICAL SOLUTIONS US, LLC

MVE BIOLOGICAL SOLUTIONS US, LLC

USA · Ball Ground
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Israel, Russia — 6 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
3listed device types
Class I 1Class II 2Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class II 7
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
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States6 registration records, 0 510(k), 0 PMA
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: MVE BIOLOGICAL SOLUTIONS US LLC · MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd · MVE BIOLOGICAL SOLUTIONS US, LLC
Same-named companies — This database also contains companies with near-identical names: MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Ball Ground

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

Accessory, Assisted Reproduction, Exempt 1Refrigerator, Freezer, Blood Storage 1Apparatus, Cell-Freezing And Reagents 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80047309242Série VOLTAClass II
BR80047309243Série MVE CryoSystemClass II
BR80047309245Série MVE Vapor ShipperClass II

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →