FDA Registration
Active
🇺🇸 United States
BRUDER HEALTHCARE COMPANY
Reg #: 1039131
·
FEI: 1039131
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
3
Classifications
9
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Registration Details
- Registration Name
- BRUDER HEALTHCARE COMPANY
- Registration Number
- 1039131
- FEI Number
- 1039131
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9240 Seward Rd
- City
- Fairfield
- State
- OH
- ZIP
- 45014
- Country
- US
Owner / Operator
- Firm Name
- The Hilsinger Company Parent, LLC
- Operator Number
- 1218954
- Address
- 575 West Street, Suite 120, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Magnet, Permanent | HPN | Class 1 | Ophthalmic | No | 2025-12-31 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2022-09-29 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2025-12-31 |
| Expressor | HNS | Class 1 | Ophthalmic | No | 2022-09-29 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2022-09-29 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2022-09-29 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2022-09-29 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2022-09-29 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-09-29 |
Proprietary Names
Bruder
Karpecki
Livengood
Collins
Thermalon
MediBeads
Eyedration
Protocold
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device