FDA Registration
Active
🇺🇸 United States
HUDSON SCIENTIFIC LLC
Reg #: 3013037032
·
FEI: 3013037032
·
Expires 2026
Products
9
Proprietary Names
9
Establishment Types
5
Classifications
9
Registration Details
- Registration Name
- HUDSON SCIENTIFIC LLC
- Registration Number
- 3013037032
- FEI Number
- 3013037032
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 103 W MAIN ST
- City
- Hudson
- State
- MI
- ZIP
- 49247
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153549
Owner / Operator
- Firm Name
- Hudson Scientific LLC
- Operator Number
- 10053280
- Address
- 103 W Main Street
- City
- Hudson
- State
- MI
- Postal Code
- 49247
- Country
- US
- Correspondent
- Yasser E Sadek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2018-03-29 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2018-11-16 |
| Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | NUP | Class 2 | General Hospital | No | 2017-06-19 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2018-03-29 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2018-05-15 |
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2018-04-25 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2019-01-28 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-01-28 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2017-02-02 |
Proprietary Names
OSSIX VOLUMAX
Breathe Ease
Alzair Allergy Blocker
OSSIX BONE
EZbra Breast Dressing
iTOVi
OSSIX PLUS
City Med Rx Powder Free Nitrile Examination Gloves
Nuvazil Silicone Gel Scar Dressings
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device