FDA Registration
Active
🇮🇳 India
POLY MEDICURE LTD.
Reg #: 9616991
·
FEI: 3003205539
·
Expires 2026
Products
12
Proprietary Names
6
Establishment Types
1
Classifications
12
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Registration Details
- Registration Name
- POLY MEDICURE LTD.
- Registration Number
- 9616991
- FEI Number
- 3003205539
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot No. 115, 116 & 117, Sector 59, HSIIDC Industrial area, Ballabgarh
- City
- Faridabad Haryana
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K231401
Owner / Operator
- Firm Name
- Poly Medicure Limited
- Operator Number
- 9044462
- Address
- Plot No. 115, 116 & 117, Sector 59, HSIIDC Industrial Area, Ballabgarh
- City
- Faridabad
- State
- Haryana
- Postal Code
- 121004
- Country
- IN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-11-13 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2017-06-23 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-04-21 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2020-04-21 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2020-04-21 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2020-04-21 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2020-04-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2020-04-21 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2020-04-21 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-08-19 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-04-21 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-02-24 |
Proprietary Names
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
POLYMED
Safety-Vac Sterile Connection Tube
Ultravak Set
Safety Vac
Polyshield, Polyshield Adva, Polyshield BC, Polyshield BC Adva, Polyguard+, Polyguard Adva, Polyguard BC, Polyguard BC Adva
Establishment Types
Manufacture Medical Device