FDA Registration
Active
🇵🇱 Poland
Pediatric Biteguard
Reg #: 3010806663
·
FEI: 3010806663
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INORIS MEDICAL SP. Z O.O.
- Registration Number
- 3010806663
- FEI Number
- 3010806663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ul. Zmkowa 9
- City
- Kowary Dolnoslaskie
- Country
- PL
Owner / Operator
- Firm Name
- Inoris Medical Sp. z o.o.
- Operator Number
- 10046303
- Address
- ul. Zmkowa 9
- City
- Kowary
- State
- Dolnoslaskie
- Postal Code
- 58-530
- Country
- PL
- Correspondent
- Pawel Gotowala
US Agent
- Business Name
- KAL-MED, LLC
- Contact Name
- Robert Kaliski
- Address
- 570 PERCIVAL AVE
- City
- Kensington
- State
- CT
- ZIP
- 06037
- Country
- US
- [email protected]
- Phone
- 585 6334225
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2014-03-03 |
Proprietary Names
Pediatric Biteguard
Clip-On Biteguard
Adult Biteguard
Scanhead protection cover
Gastroguard
Tubeguard
Soft Adult Biteguard
Establishment Types
Manufacture Medical Device