Microtek Dominicana S A

FDA Filings

This page includes the latest FDA filings for Microtek Dominicana S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8043817
• FEI Number: 3003094575
• Name: MICROTEK DOMINICANA, S.A.
• Owner & Operator: Ecolab
• Contact Address: 1 Ecolab Place ; Saint Paul MN 55102 US
• Official Correspondent:
  • Raghu Jainapur
  • x-651-2503570-x
• US Agent:
  • Raghu Jainapur
  • 651 2503570
  • 651 2502959
  • raghu.jainapur@ecolab.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ZONA FRANCA No. 2 ; LA ROMANA La Romana, -- DO
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
EYY MICROTEK DOMINICANA, S.A. [Ecolab]	Lithotomy Drape	2018-03-16
PMN K854613 | HMT MICROTEK DOMINICANA, S.A. [Ecolab]	Ocudrape	2017-12-18
LHC MICROTEK DOMINICANA, S.A. [Ecolab]	Fluid Warming and Surgical Slush	2017-08-10
LHC MICROTEK DOMINICANA, S.A. [Ecolab]	CoreTemp Surgical Solution Warming System	2017-08-10
LHC MICROTEK DOMINICANA, S.A. [Ecolab]	CoreTemp Surgical Solution Drape, Sterile	2017-08-10
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Vari-Lens	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Perfect Pouch	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	ORS Slush and Warmer Drapes, Sterile and Non-Sterile	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	ORS Scope Pillow Warmer Drape, Sterile and Non-Sterile	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Patient Drapes	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Equipment Drapes	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Microscope / Laser Drape - Equipment Drape	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Lingeman	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	IntraTemp ThermaBasin	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Genesys	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Elastifit	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Disposable Equipment Covers	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	CoreTemp Surgical Solution Drape, Sterile	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Clearlens	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	Armatec	2017-07-25
PUI MICROTEK DOMINICANA, S.A. [Ecolab]	1 Drape	2017-07-25
BYY MICROTEK DOMINICANA, S.A. [Ecolab]	Lingeman	2017-04-20
PMN K052395 | KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Volcano	2017-03-15
FTA MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek	2016-09-02
PMN K142173 | LHC MICROTEK DOMINICANA, S.A. [Ecolab]	ORS Scope Pillow Warmer Drape	2014-12-31
PMN K142080 | LHC MICROTEK DOMINICANA, S.A. [Ecolab]	Non-Sterile ORS Drapes	2014-09-09
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Vari-Lens	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Perfect Pouch	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Patient Drapes	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Equipment Drapes	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Microscope / Laser Drape - Equipment Drape	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Lingeman	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Genesys	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Elastifit	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	EZ Sert	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Clearlens	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Armatec	2014-09-03
KKX MICROTEK DOMINICANA, S.A. [Ecolab]	1 Drape	2014-09-03
PMN K132386 | FYA MICROTEK DOMINICANA, S.A. [Ecolab]	TotalShield Surgical Helmet System	2014-01-17
PMN K843262 | JOP MICROTEK DOMINICANA, S.A. [Ecolab]	Rolled Probe Cover	2013-08-15
PMN K051979 | OCV MICROTEK DOMINICANA, S.A. [Ecolab]	Scope Cradle	2013-08-06
PMN K051979 | OCT MICROTEK DOMINICANA, S.A. [Ecolab]	Scope Cradle	2013-08-06
KQZ MICROTEK DOMINICANA, S.A. [Ecolab]	Stabilization Kit	2012-08-20
PMN K050776 | LFL MICROTEK DOMINICANA, S.A. [Ecolab]	Misonix Irrigation Tube Set	2012-04-10
PMN K023282 | LHC MICROTEK DOMINICANA, S.A. [Ecolab]	ORS	2012-04-02
PMN K090308 | JOW MICROTEK DOMINICANA, S.A. [Ecolab]	Strycker Ascent	2012-01-11
PMN K914702 | FXP MICROTEK DOMINICANA, S.A. [Ecolab]	DePuy	2011-11-30
PMN K914077 | LYU MICROTEK DOMINICANA, S.A. [Ecolab]	DePuy	2011-11-30
PMN K900310 | LYU MICROTEK DOMINICANA, S.A. [Ecolab]	DePuy	2011-11-30
PMN K110358 | JOW MICROTEK DOMINICANA, S.A. [Ecolab]	Venodyne	2011-11-30
ILO MICROTEK DOMINICANA, S.A. [Ecolab]	Donjoy	2011-11-29
KPY MICROTEK DOMINICANA, S.A. [Ecolab]	Drape Armour	2011-10-07
KGX MICROTEK DOMINICANA, S.A. [Ecolab]	Polar Dressing	2009-12-17
PMN K980066 | BTM MICROTEK DOMINICANA, S.A. [Ecolab]	CPR Filtershield	2009-12-05
PMN K950770 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR Microshield	2009-12-05
PMN K950770 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR Microshield II	2009-12-05
PMN K890917 | KGX MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Patient Drapes with Microban	2009-12-05
PMN K882724 | KKX MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Probe Covers	2009-12-05
PMN K882724 | KKX MICROTEK DOMINICANA, S.A. [Ecolab]	IsoSilk	2009-12-05
PMN K003194 | FYA MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek	2009-12-05
CAE MICROTEK DOMINICANA, S.A. [Ecolab]	Salt Airway	2008-05-21
CAE MICROTEK DOMINICANA, S.A. [Ecolab]	S.A.L.T.	2008-05-21
KME MICROTEK DOMINICANA, S.A. [Ecolab]	OREX MEDICAL BEDDING	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	Microtek Disposable Baby Blanket	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	MICROTEK DISPOSABLE BEDDING	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	MEDICAL#GENERAL HOSPITAL	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	DISPOSABLE BEDDING	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	CleanOp: bedding and cleaning supplies	2006-02-16
KME MICROTEK DOMINICANA, S.A. [Ecolab]	BEDDING	2006-02-16
PMN K953414 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR MICROSHIELD	2005-12-21
PMN K953414 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR MICROMASK	2005-12-21
PMN K950769 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR MICROSHIELD	2005-12-21
PMN K950769 | CBP MICROTEK DOMINICANA, S.A. [Ecolab]	CPR MICROMASK	2005-12-21
PMN K001802 | JOW MICROTEK DOMINICANA, S.A. [Ecolab]	Venodyne	2005-12-21
PMN K001802 | JOW MICROTEK DOMINICANA, S.A. [Ecolab]	PUMP	2005-12-21
PMN K001802 | JOW MICROTEK DOMINICANA, S.A. [Ecolab]	COMPRESSION LIMB SLEEVE	2005-12-21
KGY MICROTEK DOMINICANA, S.A. [Ecolab]	MICROTEK INTESTINE BAG	2005-12-21
KGY MICROTEK DOMINICANA, S.A. [Ecolab]	INTESTINE BAG	2005-12-21
FQM MICROTEK DOMINICANA, S.A. [Ecolab]	Esmark	2005-12-21
MRI MICROTEK DOMINICANA, S.A. [Ecolab]	Immobile-Vac	2001-06-19
MRI MICROTEK DOMINICANA, S.A. [Ecolab]	Econo-Vac	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	MEDICAL DEVICES INTERNATIONAL EMS I	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	LEG	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	KLE SPLINT	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	Immobile-Vac	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	Econo-Vac	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	ARMBOARDS	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	ARM	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	9"	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	5"	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	18" LONG	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	,	2001-06-19
FYH MICROTEK DOMINICANA, S.A. [Ecolab]	& WRIST/ANKLE SPLINT	2001-06-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929107379	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	728 CAS
20200929107362	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	630 CAS
20200929107375	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	1150 CAS
20200929107383	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	2834 CAS
2020092562390	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	2346 CAS
2020092459560	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	2346 CAS
2020092381916	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	2662 CAS
2020092296745	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL DEVICES	814 CAS