FDA Registration
Active
🇳🇱 Netherlands
VIROCLINICS BIOSCIENCES B.V.
Reg #: 3010600155
·
FEI: 3010600155
·
Expires 2026
Products
7
Proprietary Names
4
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- VIROCLINICS BIOSCIENCES B.V.
- Registration Number
- 3010600155
- FEI Number
- 3010600155
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Marconistraat 16
- City
- Rotterdam Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K042970
Owner / Operator
- Firm Name
- NJK & Associates
- Operator Number
- 10045793
- Address
- Marconistraat 16
- City
- Rotterdam
- State
- Zuid-Holland
- Postal Code
- 3029 AK
- Country
- NL
- Correspondent
- Natalie J Kennel
US Agent
- Business Name
- NJK & Associates & Inc.
- Contact Name
- Natalie Kennel
- Address
- 13721 Via Tres Vista
- City
- San Diego
- State
- CA
- ZIP
- 92129
- Country
- US
- [email protected]
- Phone
- 858 7050350
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2013-12-30 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2013-12-30 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2016-09-13 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2018-10-02 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2021-02-01 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2013-12-30 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-12-30 |
Proprietary Names
Hygiene Mask - 2PLY-WHITE-EARLOOPS
UTM Tubes
Micro Touch Latex Exam Gloves
FLOOSwabs
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device