FDA Registration
Active
🇧🇪 Belgium
enziMed Instrument Washer (20L)
Reg #: 3032580961
·
FEI: 3032580961
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ONELIFE
- Registration Number
- 3032580961
- FEI Number
- 3032580961
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenue Albert Einstein 15
- City
- Ottignies-Louvain-la-Neuve Brabant Wallon
- Country
- BE
Owner / Operator
- Firm Name
- OneLife
- Operator Number
- 10091356
- Address
- Avenue Albert Einstein 15
- City
- Ottignies-Louvain-la-Neuve
- State
- Brabant Wallon
- Postal Code
- 1348
- Country
- BE
- Correspondent
- Martine Weickmans
US Agent
- Business Name
- Simple Path LLC
- Contact Name
- Tawney Schwarz
- Address
- 712 Lyndhurst St Unit 321
- City
- Dunedin
- State
- FL
- ZIP
- 34698
- Country
- US
- [email protected]
- Phone
- 910 5150918
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2024-09-04 |
Proprietary Names
enziMed Instrument Washer (20L)
enziMed Standard (25L)
enziMed Standard (1000L)
enziDent Flow (2x1L)
enziMed Prevent MAX (6x1L)
Detect 2 Colorant (6x950ml)
enziMed Prevent MAX (5L)
Detect 2 Colorant (2x5L)
enziMed Prevent MAX (10L)
enziMed Dry (20L)
Detect 2 Colorant (kit)
enziDent Flow (5L)
enziMed Dry (5L)
enziMed ALLKLEAN (600L)
enziMed ALLKLEAN (1000L)
enziDent(2x1L)
enziMed Pre-Cleaner (1x5L)
enziMed Standard (6x1L)
enziMed Instrument Washer (5L)
enziDent(5L)
enziMed Prevent MAX (200L)
enziMed ALLKLEAN (20L)
enziMed Instrument Washer (10L)
enziMed Pre-Cleaner (6x750ml)
enziMed Dry (10L)
enziMed ALLKLEAN (200L)
enziMed Standard (10L)
enziQure (2x1L)
enziMed ALLKLEAN (5L)
enziMed Standard (5L)
enziMed ALLKLEAN (10L)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device