FDA Registration
Active
🇳🇱 Netherlands
2.3/10 MEEK Micrograft gauze, expansion 1:3, with cork pla
Reg #: 3008950755
·
FEI: 3008950755
·
Expires 2025
Products
1
Proprietary Names
133
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HUMECA BV
- Registration Number
- 3008950755
- FEI Number
- 3008950755
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
Proprietary Names
2.3/10 MEEK Micrograft gauze, expansion 1:3, with cork pla
3.MAC02 MEEK sterilization case 434x254x172 mm
5.BLPG10 Blades for Padgett® dermatomes, model B, C and S,
4,069 Spare part: D42 front beam, P421611
5.D42BL5PS D42 derm.blades, box 5 pcs
Micrograft gauze with cork plate, 1:4, 10 pcs
Humeca D42 dermatome blade, 10 pcs
4.BC6V Dermatome battery cartridge Ni-MH, 6V, 880 mAh
4,065 Spare part: power shaft, small diameter model
3.KN13/38 MEEK cutting axis with 13 ceramic coated circular
Micrograft gauze with cork plate, 1:4, 40 pcs
MEEK set hand drivers, complete
2.3/10 Humeca Micrograft gauze, expansion 1:3, with cork pl
5.BLPG10 Blades for Padgett® dermatomes, model B, C and S,
2.9/10 MEEK Micrograft gauze, expansion 1:9, with cork pla
4,008 Spare part: D80 blade cover
3.HD/BLO MEEK cutting machine, hand driven (block model) wit
4.D80 D80 dermatome without battery- and motor cartrid
4,033 Spare part: motor cartridge metal tube (tube only, not
Humeca D80 dermatome blade, 10 pcs
Width reducing clamp D80 65-22 for new model blade cover
4.BC7.4V2400 Dermatome battery cartridge Li-Ion, 7.4V, 2400
5.D80BL5PS D80 derm.blades, box 5pcs
2.3/40 MEEK Micrograft gauze, expansion 1:3, with cork pla
4.SF01 Steri4.SFle funnel for small diameter dermatome shaft
4,014 Spare part: closing cap Ni-MH
4.SB01 Sober hand dermatome, set incl. 10 blades
4.D42CL36D42 width reducing clamp 36 mm.
Micrograft gauze with cork plate, 1:9, 10 pcs
4.MCX15 Dermatome motor cartridge, long (new) version
3.CB02 MEEK double cutting block with two cork holders
4.D80CL65 D80 width reducing clamp 65 mm.
2.9/10 Humeca Micrograft gauze, expansion 1:9, with cork pl
2.4/10 MEEK Micrograft gauze, expansion 1:4, with cork pl
4.SU01 Dermatome charger support unit
4,059 Spare part: Power switch support (window) with screws
3.SW01 MEEK serrated wedge (cam)
4,058 Spare part: Power switch + 2x M2x4 screws
4,064 Spare part: Viton rubber ring for motor cartridge
4.D42STS D42 dermatome, complete set, in suitcase
4.UPG1 Upgrade D42 or D80 from Ni-Mh 880mAh to Li-Ion 1200mA
4.D42 D42 dermatome without battery- and motor cartridge
4.9C94142 Dermatome battery charger Li-Ion with adaptors
Micrograft gauze with cork plate, 1:3, 40 pcs
3.MAC01 MEEK sterilization case 620x260x107 mm
4,017 Spare part: closing cap Li-Ion
4.ACS410 Dermatome battery charger Ni-MH with adaptors
2.3/10 PS Mic gauze, 1:3 with cork plate
2.6/10PS Mic gauze 1:6 with cork plate
4,081 Set L-keys for Humeca dermatomes
3.CP4 MEEK pneumatic foot pedal with connectors and hose
D80 Dermatome set
4.UPG4 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t
5.BLZM10 Blades for Zimmer® dermatomes
4.SB01 Sober hand dermatome, set incl. 10 blades
2.4/40 MEEK Micrograft gauze, expansion 1:4, with cork plate
2.4/10PS Mic gauze, 1:4 with cork plate
3.SHD MEEK hand drive set, block version (compatible with pn
5.BL4245-PS Bld.Aesculap cordless derm, box 3
4.D80CL50 D80 width reducing clamp 50 mm.
4.D42CL30 D42 width reducing clamp 30 mm.
4,066 Spare part: power shaft, large diameter model
4,071 Spare part, D42 front beam assy P421600/2
2.6/10 Humeca Micrograft gauze, expansion 1:6, with cork pl
2.6/10 MEEK Micrograft gauze, expansion 1:6, with cork pla
4.BF7.4V2400 Battery pack, Li-Ion, 7.4V, 2400 mAh (only pack
5.BL4245 Blades for Aesculap® cordless dermatomes, box 10
4.D42 AC1 D42 sterilization case
4,070 Spare part: D80 front beam, P801611
4.D80CL35 D80 width reducing clamp 35 mm.
3.MD/AUT MEEK cutting machine, automatic, without block
4.shaft40-45 Exchange dermatome Ni-MH model into 2400 Li-Ion
2.9/40 MEEK Micrograft gauze, expansion 1:9, with cork pl
4.BC7.4V1200 Dermatome battery cartridge Li-Ion, 7.4V, 1200
3.MD Humeca Micrograft gauze, expansion 1:6, with cork plate
5.BLBPG10-PS BLD. for Padgett derm model B,C &S box 3
4.ANS-HC Dermatome battery charger Li-Ion 400 mA with adapte
4,015 Spare part: D42 covering plate, stainless steel
Micrograft gauze with cork plate, 1:2, 10 pcs
Micrograft gauze with cork plate, 1:6, 10 pcs
Humeca blade for Aesculap / Acculan dermatome, 10 pcs
Width reducing clamp D42 20-20 for new model blade cover
Micrograft gauze with cork plate, 1:9, 40 pcs
Humeca blade for Zimmer 8801-8821 dermatome, 10 pcs
Serrated wedge (cam) for double cutting block
Width reducing clamp D42 36-21 for new model blade cover
Humeca blade for Padgett model B, C, and S dermatomes, 10 pcs
Micrograft gauze with cork plate, 1:2, 40 pcs
D42 Dermatome set
3.RM004 MEEK pneumatic block motor with connectors and coupl
3.BL38MEEK circular ceramic coated blade, diameter 38 mm.
4.ANS-LC Dermatome battery charger Li-Ion, 1200 mA with adap
Width reducing clamp D80 50-21 for new model blade cover
2.6/40 MEEK Micrograft gauze, expansion 1:6, with cork pl
4,072 Spare part, D80 front beam assy, P801600
5.BLSB10 Blades for Sober hand dermatome, box 10 pcs.
3.CH01 MEEK cork holder
2.JG598 STERILIT® oil for surgical instruments, bottle 50 ml
4.BF6V880 Battery pack, Ni-MH, 6V, 880 mAh (only pack, not c
3.BL38 MEEK circular ceramic coated blade, diameter 38 mm.
4.UPG3 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t
4.SCL Sterile clamp
4.D80AC1 D80 sterilization case
3.CA01 MEEK cutting aid 41x41 mm.
4.BF7.4V1200 Battery pack, Li-Ion, 7.4V, 1200 mAh (only pack
3.MD MEEK cutting machine, motor driven, without cutti
4,009 Spare part: D42 blade cover
5.BL4245 Blades for Aesculap® cordless dermatomes, box 10
5.BLZM10-PS BLD. for Zimmer derm. 8801 & 8821 Box 3
4.UPG2 Upgrade D42 or D80 from Ni-Mh 880 mAh to Li-Ion 1200m
2.4/10 Humeca Micrograft gauze, expansion 1:4, with cork p
3.HD/CYL MEEK cutting machine, hand driven (cylindrical mode
4.D80STS D80 dermatome, complete set, in suitcase
4,053 Spare part: dermatome lever
4.AN5207 Dermatome battery charger Li-Ion, small model 800 m
4.SF02 Sterile funnel for large diameter dermatome shaft
4,061 Spare part: microswitch
4.MC960 Dermatome motor cartridge, short (old) version
MEEK set machine drivers, complete
Micrograft gauze with cork plate, 1:3, 10 pcs
Width reducing clamp D80 35-20 for new model blade cover
Micrograft gauze with cork plate, 1:6, 40 pcs
3.CH01 MEEK cork holder
4,067 Spare part: hinge pin blade cover
5.D80BL10 D80 dermatome blades, box 10 pcs.
4,016 Spare part: D80 covering plate, stainless steel
4.BC6V Dermatome battery cartridge Ni-MH, 6V, 880 mAh
4.D42CL20 D42 width reducing clamp 20 mm
3.CB01 Meeksingle cutting block with cork holder
3.MD/GW MEEK cutting machine, motor driven, gearwheels, with
2.9/10PS Mic Gauze, 1:9, with cork plate
5.D42BL10 D42 dermatome blades, box 10 pcs.
4,062 Spare part: dermatome motor Amax 32 (only motor, no ca
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device