Fresenius Hemocare GmbH
Friedberg Hesse, DE
FRESENIUS HEMOCARE GMBH appears in FDA device records in Friedberg Hesse, DE. FDA records list no 510(k) clearances, 21 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004634229 | 3004634229 | FRESENIUS HEMOCARE GMBH | Gruener Weg 10, Friedberg Hesse D-61169 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CACApparatus, Autotransfusion
- KSQDevice, Blood Mixing And Blood Weighing
- GHYHematocrit, Tube, Rack, Sealer, Holder
- MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- KSBSet, Transfer (Blood/Plasma)
- KSSSupplies, Blood-Bank
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1086-03 | Prosorba Protein A Immunoadsorption Column | No package insert | Terminated | ||
| Z-0906-03 | ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set. | Sterility may be compromised | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Fresenius Hemocare GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain