Miltenyi Biotec B. V. & Co. KG
Germany · Bergisch Gladbach
✓ Record-verifiedregistrations found in 9 markets
This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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 comparableCNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 0Class III 0unclassified 2
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
5 including historic records
TWTaiwanTFDA
3valid device licences
Class II 1Class III 2
SGSingaporeHSA SMDR
13device registrations
CLASS B 1CLASS D 12
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
16active ARTG entries
Class I 3Class III 5IIa 4IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 4
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.
Australia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
How these numbers were verified
record-verifiedCompany-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
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Miltenyi Biotec B. V. & Co. KG · Miltenyi Biotec B. V. & Co. KG Branch Teterow · MILTENYI BIOTEC B.V. & CO. KG · MILTENYI BIOTEC GMBH
Same-named companies — This database also contains companies with near-identical names: MILTENYI BIOTEC GMBH. Company name alone cannot separate their registrations, so the figures below may include either.
Company information
- Country
- Germany
- City
- Bergisch Gladbach
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
Container, Frozen Donor Tissue Storage 1Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) 1Reagents, Specific, Analyte 1