FDA Registration
Active
🇧🇪 Belgium
DEUFOL WAREMME OPERATIONS
Reg #: 3030172764
·
FEI: 3030172764
·
Expires 2026
Products
11
Proprietary Names
54
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- DEUFOL WAREMME OPERATIONS
- Registration Number
- 3030172764
- FEI Number
- 3030172764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rue du Parc Industriel 29
- City
- Waremme Liege
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K050184
Owner / Operator
- Firm Name
- Deufol Waremme Operations
- Operator Number
- 10089314
- Address
- Rue du Parc Industriel 29
- City
- Waremme
- State
- Liege
- Postal Code
- 4300
- Country
- BE
- Correspondent
- Ronald Schrooten
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177 ext. 23666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2024-12-03 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-12-18 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-11-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-12-18 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2023-12-18 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2023-12-15 |
Proprietary Names
Z-Flo Fluidized Positioner
Biogel PI
Mepore Film
Mepitel One
Mepitel
Mepitel Film
Exufiber Ag+
Barrier Medical Face Mask
Mepilex Border
Melgisorb Plus, Cavity
Mepore Film & Pad
Mepilex Lite
Mepilex Border Flex Lite
Mepilex XT
Mepilex
Melgisorb Plus
Lyofoam Max
Mesalt
Mepore
Mepilex Border Flex
Mepore Pro
Mepilex Up
Mepilex Border Lite
Mepilex Border Sacrum
Mestopore
Mepilex Heel
Mepilex Border Post-Op
Exufiber
Mextra Superabsorbent
Mepilex Transfer
Alldress
Mepilex Border Heel
Mepore Film and Pad
Mepitac
Mefix
Mepiform
Barrier Nurse's Cap
Headcovering
Barrier Surgical Hood
Barrier Surgical Cap
Elset
Setopress
Tubigrip
Tubifast
Melgisorb Ag
Biogel PI Micro Indicator Underglove
Biogel PI Micro
Avance Solo NPWT System
Avance Solo
Normlgel Ag
Mepilex Border Ag
Mepilex Heel Ag
Mepilex Border Sacrum Ag
Mepilex Border Post Op Ag
Establishment Types
Export Device to the United States But Perform No Other Operation on Device