FDA Registration
Active
🇳🇱 Netherlands
HUMECA BV
Reg #: 3008950755
·
FEI: 3008950755
·
Expires 2026
Products
6
Proprietary Names
56
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- HUMECA BV
- Registration Number
- 3008950755
- FEI Number
- 3008950755
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Oostermaat 5
- City
- Borne Overijssel
- Country
- NL
Owner / Operator
- Firm Name
- Humeca BV
- Operator Number
- 10035227
- Address
- Oostermaat 5
- City
- Borne
- State
- NL-NOTA
- Postal Code
- 7623 CS
- Country
- NL
- Correspondent
- Johannes A Van Velzen
US Agent
- Business Name
- QSR Consulting
- Contact Name
- Kenneth Kleinhenz
- Address
- 4141 Elm Rd.
- City
- Hudson
- State
- MI
- ZIP
- 49247
- Country
- US
- [email protected]
- Phone
- 619 2449573
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| 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 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-11-28 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-03-11 |
Proprietary Names
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 Humby Knife
Humeca Watson Knife
Humeca Silver Knife
Humeca Cobbett Knife
Humeca Humby Long Knife
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
Humeca MAX Mesher
Humeca® mesher
D42 Dermatome instrument Organizer
Humeca MAX Mesher Instrument Organizer
MEEK Instrument Organizer
D80 Dermatome Instrument Organizer
Humeca Mesher Instrument Organizer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility