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
Phone
619 2449573

Products

Device Name Product Code
Dermatome GFD

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