FDA Registration
Active
🇨🇦 Canada
NAJA Gastrointestinal Catheter
Reg #: 3010547268
·
FEI: 3010547268
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PAMA MANUFACTURING & STERILIZATION
- Registration Number
- 3010547268
- FEI Number
- 3010547268
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12760 boul Henri fabre
- City
- mirabel Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K223890
Owner / Operator
- Firm Name
- 8083851 Canada Inc. operating as Pama Manufacturing & steril
- Operator Number
- 10087516
- Address
- 12760 boul Henri fabre
- City
- mirabel
- State
- Quebec
- Postal Code
- J7N0A6
- Country
- CA
- Correspondent
- Gilles Chaumillon
US Agent
- Business Name
- World Wise Consulting LLC
- Contact Name
- Val Holtrop
- Address
- 7769 Nw 48th St Ste 340
- City
- Doral
- State
- FL
- ZIP
- 33166
- Country
- US
- [email protected]
- Phone
- 920 7375247
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Retention, Barium Enema With Bag | FGD | Class 2 | Gastroenterology, Urology | No | 2025-06-09 |
Proprietary Names
NAJA Gastrointestinal Catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)