FDA Registration
Active
🇺🇸 United States
CEPLAST MEDICAL DEVICES, LLC
Reg #: 3006411563
·
FEI: 3006411563
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- CEPLAST MEDICAL DEVICES, LLC
- Registration Number
- 3006411563
- FEI Number
- 3006411563
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 201 S Biscayne Blvd Ste 1200
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101348
Owner / Operator
- Firm Name
- CEPLAST MEDICAL DEVICES, LLC
- Operator Number
- 9105600
- Address
- 201 S. Biscayne Blvd. Suite 1200
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
- Correspondent
- TEREZA - REIS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2021-12-29 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2023-07-12 |
| Percussor | GWZ | Class 1 | Neurology | No | 2023-07-24 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-07-24 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2023-07-24 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2023-07-12 |
Proprietary Names
Nose Wash Syringe
Dispositivo para Lavagem Nasal Pequenos Cuidados
NOSE WASH MAX
Dalmatian Reflex Hammer
ROCKET DOSER
AGACHAMBER SPACER EXTRA
TIC - TONG FLAVORED TONGUE DEPRESSOR BIO
TIC -TONG FLAVORED TONGUE DEPRESSOR
Establishment Types
Complaint File Establishment per 21 CFR 820.198