FDA.reportPublic FDA data

MICROTEK DOMINICANA, S.A.S.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80438173003094575MICROTEK DOMINICANA, S.A.S.1N2027-01-01ZONA FRANCA II LA ROMANA DO 22000
30128119613012811961Microtek Dominicana, S.A.S.1N2027-01-01Las Americas Industrial Free Zone Park Km 22 Autopista Las Americas Santo Domingo DO 11606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3331741018465919K953673ECLIPSE PROBE COVERIYO1996-03-14
3331741185443267K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYU1991-12-02
3331741486501883K910941LIFELINER SURGICAL GLOVEFYE1991-05-09
3331741210769585K900310REPEL SURGICAL GLOVE LINERSLYU1990-03-01
3331741960898710K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASOJOP1984-08-23
3331741570214792K802146AQUASONIC 100 ULTRASOUND TRANS. GEL,IYO1980-10-10
3333961570214792K802146AQUASONIC 100 ULTRASOUND TRANS. GEL,IYO1980-10-10
3331742016500304K220333Medline Orbis LVL 3 Surgical GownFYA2022-05-18
3333962016500304K220333Medline Orbis LVL 3 Surgical GownFYA2022-05-18
3331742063348723K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04
3333962063348723K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)FYA2019-07-04
3331741819580742K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)FYA2019-04-24
3333961819580742K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)FYA2019-04-24
3331741083951362
3331741089175753
3331741102291455
3333961117161195
3331741153632022
3331741229232440
3333961229232440
3331741264467551
3331741293529924
3333961334665172
3331741334665172
3333961342977555
3331741347970760
3333961365949886
3331741387998027
3331741401584904
3331741409230394
3331741420508790
3331741457422638
3333961476404483
3331741480151585
3333961480151585
3331741521583301
3333961547131261
3331741570949122
3331741657645756
3331741686473090
3331741693392475
3331741704204612
3331741813266448
3331741863975634
3333961863975634
3331741866412946
3333961891052993
3331741902173253
3331741928586295
3331742019723967
3331742048632729
3331742068397938
3331742072064985

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FYA62022-05-18
IYO31996-03-14
LYU21991-12-02
FYE11991-05-09
JOP11984-08-23