B·R·A·H·M·S GmbH
DE-MF-000026030 · Germany · Hennigsdorf
B·R·A·H·M·S GmbH is registered in the European database on medical devices as a manufacturer, with 101 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- B·R·A·H·M·S AFP KRYPTOR CAL
- B·R·A·H·M·S AFP KRYPTOR DILUENT
- B·R·A·H·M·S CYFRA 21-1 KRYPTOR
- B·R·A·H·M·S Free ßhCG KRYPTOR
- B·R·A·H·M·S KRYPTOR BUFFER
- B·R·A·H·M·S KRYPTOR compact PLUS
- B·R·A·H·M·S MR-proADM II KRYPTOR
- B·R·A·H·M·S MR-proADM KRYPTOR CAL
- B·R·A·H·M·S MR-proANP KRYPTOR QC
- B·R·A·H·M·S NSE KRYPTOR
- B·R·A·H·M·S PCT sensitive KRYPTOR
- B·R·A·H·M·S SCC KRYPTOR
Showing 12 of 101 declared devices.
Catalogue references include 081091N, 082991N, 106172, 809075N, 811050N, 821050N.
European nomenclature codes declared: W0102152299, W0201020185, W0102152099, W0102152202, W0102152005, W0102152205.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | B.R.A.H.M.S GmbH (DE) · FDA 3003561301 |
| Devices in EUDAMED | 101 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 101 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 16.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | B.R.A.H.M.S. GMBH |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 2 |
| First licensed | 2016-02-12 |
Licence types: System (2), Single Device (1).
Licensed under: B.R.A.H.M.S KRYPTOR, B.R.A.H.M.S KRYPTOR GOLD, B.R.A.H.M.S KRYPTOR.
North American profile: Both markets. B·R·A·H·M·S GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1333941-1 | restricted | 2028-03-20 |