FDA Registration
Active
🇩🇴 Dominican Republic
Microtek Dominicana, S.A.S.
Reg #: 3012811961
·
FEI: 3012811961
·
Expires 2026
Products
11
Proprietary Names
52
Establishment Types
3
Classifications
11
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Registration Details
- Registration Name
- Microtek Dominicana, S.A.S.
- Registration Number
- 3012811961
- FEI Number
- 3012811961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Las Americas Industrial Free Zone Park, Km 22 Autopista
- City
- Las Americas Santo Domingo
- Country
- DO
Regulatory Submissions
- 510(k) Number
- K802146
Owner / Operator
- Firm Name
- Medline Industries, LP
- Operator Number
- 1417592
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- Postal Code
- 60093
- Country
- US
- Correspondent
- Stephanie Augsburg
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Rd
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-10-30 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-10-30 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-25 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-09-07 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2010-08-10 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2024-10-31 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-10-30 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2024-10-30 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2019-02-28 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-10-20 |
Proprietary Names
BSC MDU5 Bag
Microtek
Medline Light Handle Cover
Probe Cover Gel
Eclipse Surgical Drape
Medline Surgical Drape
Medline Keyboard Cover
Medline Band Bag
Medline Set Up Cover
Vari-Lens
Lingeman
Procept
AKTORmed
Microtek Patient Drapes
Medline Dome Bag
Convertors
Vital Care
Perfect Pouch
OnLume
Medline Poly-lined Drape
Medline Poly-lined Fenestrated Drape
Medline Equipment Cover
Microtek Probe Cover
Microtek Equipment Drapes
Medline Level 4 Surgical Gown
Medline
PERMANENT SLED BAG/BULK
Medline / CDS ear, nose, and throat surgical tray (kit)
Intuitive
Xi Arm and Column Drapes
Medline Orbis LVL 3 Surgical Gown
MDU5PLUS STERILE BAG
Medline surgical kits/trays and CDS modules
MEDLINE General surgery tray (kit)
Medline / Eclipse / Aurora / Sirus surgical packs
Convenience Trays & Kits CSTM
Medline Proxima
Protection Plus Disposable Underpads
Medline Disposable Underpads
FitRight
Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads
OREX MEDICAL BEDDING
DISPOSABLE BEDDING
CleanOp: bedding and cleaning supplies
Microtek Disposable Baby Blanket
Extrasorb
MICROTEK DISPOSABLE BEDDING
FitRight Extended Use Underpad
BEDDING
Ultrasorb
MEDICAL GENERAL HOSPITAL
ComfortGlide Drypad
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device