FDA Registration
Active
🇺🇸 United States
Humeca, Inc.
Reg #: 3012366928
·
FEI: 3012366928
·
Expires 2026
Products
5
Proprietary Names
51
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Humeca, Inc.
- Registration Number
- 3012366928
- FEI Number
- 3012366928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9822 NE 2nd Ave Suite 7
- City
- Miami Shores
- State
- FL
- ZIP
- 33138
- Country
- US
Owner / Operator
- Firm Name
- Humeca BV
- Operator Number
- 10035227
- Address
- Oostermaat 5
- City
- Borne
- State
- NL-NOTA
- Postal Code
- 7623 CS
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-11-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-11-28 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
Proprietary Names
Humeca Humby Knife
Humeca Watson Knife
Humeca Silver Knife
Humeca Cobbett Knife
Humeca Humby Long Knife
Humeca MAX Carrier 1:1.5, 10 pcs
Humeca MAX Carrier 1:2.5, 10 pcs
Humeca V-carrier 1.m5m, 1.5:1, 10 pcs
Humeca V-carrier 1mm, 1:1, 10 pcs
Humeca V-carrier 1mm, 3:1, 10 pcs
Humeca V-carrier 1mm, 6:1, 10 pcs
Humeca V-carrier 1.5mm, 3:1, 10 pcs
Humeca V-carrier 1.5mm, 1:1, 10 pcs
Humeca V-carrier 1mm, 1.5:1, 10 pcs
Humeca V-carrier 1mm, 2:1, 10 pcs
Humeca MAX Carrier 1:2, 10 pcs
Humeca MAX Carrier 1:1, 10 pcs
Humeca MAX Carrier 1:3, 10 pcs
Humeca MAX Carrier 1:4, 10 pcs
Humeca blade for Humby Long Knife (20cm/7.9in), 10 pcs
Humeca blade for Humby, Cobbett, and Watson Knifes (16cm/6.3 inch), 10 pcs
Humeca blade for Silver Knife Blade, 10 pcs
Humeca MAX Mesher
Humeca® mesher
Micrograft gauze with cork plate, 1:4, 40 pcs
Micrograft gauze with cork plate, 1:4, 10 pcs
D100 Dermatome Set
Micrograft gauze with cork plate, 1:2, 40 pcs
Humeca D42 dermatome blade, 10 pcs
Micrograft gauze with cork plate, 1:3, 40 pcs
Width reducing clamp D42 30-20 for new model blade cover
Micrograft gauze with cork plate, 1:9, 40 pcs
Width reducing clamp D80 35-20 for new model blade cover
D80 Dermatome set
D42 Dermatome set
Humeca blade for Aesculap / Acculan dermatome, 10 pcs
Micrograft gauze with cork plate, 1:2, 10 pcs
Micrograft gauze with cork plate, 1:6, 10 pcs
Width reducing clamp D80 50-21 for new model blade cover
MEEK set hand drivers, complete
Micrograft gauze with cork plate, 1:6, 40 pcs
MEEK set machine drivers, complete
Humeca blade for Zimmer 8801-8821 dermatome, 10 pcs
Width reducing clamp D42 36-21 for new model blade cover
Width reducing clamp D80 65-22 for new model blade cover
Micrograft gauze with cork plate, 1:3, 10 pcs
Humeca D80 dermatome blade, 10 pcs
Micrograft gauze with cork plate, 1:9, 10 pcs
Humeca blade for Padgett model B, C, and S dermatomes, 10 pcs
Humeca D100 Dermatome Blade, 10pcs
Serrated wedge (cam) for double cutting block
Establishment Types
Complaint File Establishment per 21 CFR 820.198