FDA.reportPublic FDA data

FRESENIUS HEMOCARE NETHERLANDS B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96109693002807758FRESENIUS HEMOCARE NETHERLANDS B.V.1N2020-04-25RUNDE ZZ 41 EMMER-COMPASCUUM Drenthe NL NL-7881 HM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165661277775605K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTN1999-06-29
165661000885538K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECAC1999-02-01
165661463244018K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCAC1997-06-13
165661483466983K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATORLKN1996-07-31
165661123218824K960006C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEMCAC1996-07-31
165661206380430K895435FRESENIUS AS 104 CELL SEPARATORLKN1990-11-02
165661902906108K192368CATSmartCAC2019-09-27
165661116719526K180831CATSmartCAC2018-12-10
165661052083267K160735CATSmartCAC2016-09-16
165661995920744K060734FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)LKN2006-09-05
165662060316092K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAWCAC2001-07-23
165661930482919BK880007

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAC72019-09-27
LKN32006-09-05
DTN11999-06-29