FDA Registration
Active
🇲🇹 Malta
MICROTEK MEDICAL MALTA LIMITED
Reg #: 3006581049
·
FEI: 3006581049
·
Expires 2026
Products
4
Proprietary Names
23
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- MICROTEK MEDICAL MALTA LIMITED
- Registration Number
- 3006581049
- FEI Number
- 3006581049
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SORBONNE CENTRE F20, MOSTA TECHNOPARK
- City
- Mosta
- Country
- MT
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 |
|---|---|---|---|---|---|
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2024-10-30 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-10-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-10-30 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-25 |
Proprietary Names
Disposable Equipment Covers
Probe Cover Gel
MTP Extraction Bag
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device