FDA Registration
Active
🇺🇸 United States
ROCHAL TECHNOLOGIES LLC
Reg #: 3021784063
·
FEI: 3021784063
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ROCHAL TECHNOLOGIES LLC
- Registration Number
- 3021784063
- FEI Number
- 3021784063
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12000 Network Blvd, Suite B200
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K955506
Owner / Operator
- Firm Name
- Rochal Technologies LLC
- Operator Number
- 10083087
- Address
- 12000 Network Blvd, Suite B200
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- William Coulston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2023-08-04 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2021-10-25 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2023-04-04 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2021-10-25 |
Proprietary Names
Hycol
CellerateRX
BIAKOS Antimicrobial Wound Gel
BIASURGE Advanced Surgical Solution
Hycure Oral / Hycure Oral Smart Gel
Silvakollagen Gel
Hyprochon
Silvakollagen
BIAKOS Antimicrobial Skin & Wound Irrigation Solution
BIAKOS Antimicrobial Skin & Wound Cleanser
Antimicrobial Barrier Film Dressing
No Sting Skin Protectant
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility