FDA Registration
Active
🇳🇱 Netherlands
SANICURE BV
Reg #: 3012494290
·
FEI: 3012494290
·
Expires 2025
Products
11
Proprietary Names
0
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- SANICURE BV
- Registration Number
- 3012494290
- FEI Number
- 3012494290
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Evert van de Beekstraat 104
- City
- SCHIPHOL Noord-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K952307
Owner / Operator
- Firm Name
- Sanicure BV
- Operator Number
- 10052769
- Address
- Evert van de Beekstraat 104
- City
- SCHIPHOL
- State
- Noord-Holland
- Postal Code
- 11118 CL
- Country
- NL
- Correspondent
- Josef Hofer
US Agent
- Business Name
- SSPT Inc
- Contact Name
- Celia Parnicky
- Address
- 100 Se 3rd Ave Fl 10 Ste 1000
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33394
- Country
- US
- [email protected]
- Phone
- 954 2610657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2019-01-09 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2019-01-09 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2019-01-09 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device