FDA Registration
Active
🇺🇸 United States
PLANDOCS USA, INC.
Reg #: 3030446758
·
FEI: 3030446758
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PLANDOCS USA, INC.
- Registration Number
- 3030446758
- FEI Number
- 3030446758
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 500 N State College Blvd Ste 1100
- City
- Orange
- State
- CA
- ZIP
- 92868
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151090
Owner / Operator
- Firm Name
- Plandocs USA, Inc.
- Operator Number
- 10091336
- Address
- 500 N. State College Blvd,, Suite 1100
- City
- Orange
- State
- CA
- Postal Code
- 92868
- Country
- US
- Correspondent
- Jamie Park
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2025-04-24 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2026-02-13 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2025-03-25 |
Proprietary Names
PD NANO CANNULA
DermiSync
Lumeon_Pro
Dr.pen A20
Establishment Types
Repack or Relabel Medical Device