Humeca Inc

FDA Filings

This page includes the latest FDA filings for Humeca Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Humeca Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3012366928
FEI Number3012366928
NameHumeca, Inc.
Owner & OperatorHumeca BV
Contact AddressOostermaat 5
Borne NL-NOTA 7623 CS NL
Official Correspondent
  • Johannes A Van Velzen
  • 31-74-7271001-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address8681 Highway 92 suite 308
Woodstock, GA 30189 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Humeca, Inc. [Humeca BV]
6.V15-3.0 V-carrier, 1:3, for Humeca and Aesculap? / B.Braun2011-02-14
Humeca, Inc. [Humeca BV]
6.V15-2.0 V-carrier, 1:2, for Humeca and Aesculap? / B.Braun? meshers, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
6.V15-1.5 V-carrier, 1:1.5, for Humeca and Aesculap? / B.Bra2011-02-14
Humeca, Inc. [Humeca BV]
6.V15-1.0 V-carrier, 1:1, for Humeca and Aesculap? / B.Braun2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-6.0 V-carrier, 1:6, for Humeca and Zimmer? meshers, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-3.0 V-carrier, 1:3, for Humeca and Zimmer? mes2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-2.0 V-carrier, 1:2, for Humeca and Zimmer? meshers, bo2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-1.5 V-carrier, 1:1.5, for Humeca and Zimmer? meshers,2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-1.0 V-carrier, 1:1, for Humeca and Zimmer? meshers, bo2011-02-14
Humeca, Inc. [Humeca BV]
5.D80BL5PS D80 derm.blades, box 5pcs2011-02-14
Humeca, Inc. [Humeca BV]
5.D80BL10 D80 dermatome blades, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
5.D42BL5PS D42 derm.blades, box 5 pcs2011-02-14
Humeca, Inc. [Humeca BV]
5.D42BL10 D42 dermatome blades, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
5.BLZM10-PS BLD. for Zimmer derm. 8801 & 8821 Box 32011-02-14
Humeca, Inc. [Humeca BV]
5.BLZM10 Blades for Zimmer? dermatomes2011-02-14
Humeca, Inc. [Humeca BV]
5.BLSB10 Blades for Sober hand dermatome, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
5.BLPG10 Blades for Padgett? dermatomes, model B, C and S,2011-02-14
Humeca, Inc. [Humeca BV]
5.BLBPG10-PS BLD. for Padgett derm model B,C &S box 32011-02-14
Humeca, Inc. [Humeca BV]
5.BL4245-PS Bld.Aesculap cordless derm, box 32011-02-14
Humeca, Inc. [Humeca BV]
5.BL4245 Blades for Aesculap? cordless dermatomes, box 102011-02-14
Humeca, Inc. [Humeca BV]
4.shaft40-45 Exchange dermatome Ni-MH model into 2400 Li-Ion2011-02-14
Humeca, Inc. [Humeca BV]
4.UPG4 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t2011-02-14
Humeca, Inc. [Humeca BV]
4.UPG3 Upgrade D80-set from Ni-Mh 880mAh or Li-Ion 1200mAh t2011-02-14
Humeca, Inc. [Humeca BV]
4.UPG2 Upgrade D42 or D80 from Ni-Mh 880 mAh to Li-Ion 1200m2011-02-14
Humeca, Inc. [Humeca BV]
4.UPG1 Upgrade D42 or D80 from Ni-Mh 880mAh to Li-Ion 1200mA2011-02-14
Humeca, Inc. [Humeca BV]
4.SU01 Dermatome charger support unit2011-02-14
Humeca, Inc. [Humeca BV]
4.SF02 Sterile funnel for large diameter dermatome shaft2011-02-14
Humeca, Inc. [Humeca BV]
4.SF01 Steri4.SFle funnel for small diameter dermatome shaft2011-02-14
Humeca, Inc. [Humeca BV]
4.SCL Sterile clamp2011-02-14
Humeca, Inc. [Humeca BV]
4.SB01 Sober hand dermatome, set incl. 10 blades2011-02-14
Humeca, Inc. [Humeca BV]
4.MCX15 Dermatome motor cartridge, long (new) version2011-02-14
Humeca, Inc. [Humeca BV]
4.MC960 Dermatome motor cartridge, short (old) version2011-02-14
Humeca, Inc. [Humeca BV]
4.D80STS D80 dermatome, complete set, in suitcase2011-02-14
Humeca, Inc. [Humeca BV]
4.D80CL65 D80 width reducing clamp 65 mm.2011-02-14
Humeca, Inc. [Humeca BV]
4.D80CL50 D80 width reducing clamp 50 mm.2011-02-14
Humeca, Inc. [Humeca BV]
4.D80CL35 D80 width reducing clamp 35 mm.2011-02-14
Humeca, Inc. [Humeca BV]
4.D80AC1 D80 sterilization case2011-02-14
Humeca, Inc. [Humeca BV]
4.D80 D80 dermatome without battery- and motor cartrid2011-02-14
Humeca, Inc. [Humeca BV]
4.D42STS D42 dermatome, complete set, in suitcase2011-02-14
Humeca, Inc. [Humeca BV]
4.D42CL36D42 width reducing clamp 36 mm.2011-02-14
Humeca, Inc. [Humeca BV]
4.D42CL30 D42 width reducing clamp 30 mm.2011-02-14
Humeca, Inc. [Humeca BV]
4.D42CL20 D42 width reducing clamp 20 mm2011-02-14
Humeca, Inc. [Humeca BV]
4.D42 D42 dermatome without battery- and motor cartridge2011-02-14
Humeca, Inc. [Humeca BV]
4.D42 AC1 D42 sterilization case2011-02-14
Humeca, Inc. [Humeca BV]
4.BF7.4V2400 Battery pack, Li-Ion, 7.4V, 2400 mAh (only pack2011-02-14
Humeca, Inc. [Humeca BV]
4.BF7.4V1200 Battery pack, Li-Ion, 7.4V, 1200 mAh (only pack2011-02-14
Humeca, Inc. [Humeca BV]
4.BF6V880 Battery pack, Ni-MH, 6V, 880 mAh (only pack, not c2011-02-14
Humeca, Inc. [Humeca BV]
4.BC7.4V2400 Dermatome battery cartridge Li-Ion, 7.4V, 24002011-02-14
Humeca, Inc. [Humeca BV]
4.BC7.4V1200 Dermatome battery cartridge Li-Ion, 7.4V, 12002011-02-14
Humeca, Inc. [Humeca BV]
4.BC6V Dermatome battery cartridge Ni-MH, 6V, 880 mAh2011-02-14
Humeca, Inc. [Humeca BV]
4.ANS-LC Dermatome battery charger Li-Ion, 1200 mA with adap2011-02-14
Humeca, Inc. [Humeca BV]
4.ANS-HC Dermatome battery charger Li-Ion 400 mA with adapte2011-02-14
Humeca, Inc. [Humeca BV]
4.AN5207 Dermatome battery charger Li-Ion, small model 800 m2011-02-14
Humeca, Inc. [Humeca BV]
4.ACS410 Dermatome battery charger Ni-MH with adaptors2011-02-14
Humeca, Inc. [Humeca BV]
4.9C94142 Dermatome battery charger Li-Ion with adaptors2011-02-14
Humeca, Inc. [Humeca BV]
4,081 Set L-keys for Humeca dermatomes2011-02-14
Humeca, Inc. [Humeca BV]
4,072 Spare part, D80 front beam assy, P8016002011-02-14
Humeca, Inc. [Humeca BV]
4,071 Spare part, D42 front beam assy P421600/22011-02-14
Humeca, Inc. [Humeca BV]
4,070 Spare part: D80 front beam, P8016112011-02-14
Humeca, Inc. [Humeca BV]
4,069 Spare part: D42 front beam, P4216112011-02-14
Humeca, Inc. [Humeca BV]
4,067 Spare part: hinge pin blade cover2011-02-14
Humeca, Inc. [Humeca BV]
4,066 Spare part: power shaft, large diameter model2011-02-14
Humeca, Inc. [Humeca BV]
4,065 Spare part: power shaft, small diameter model2011-02-14
Humeca, Inc. [Humeca BV]
4,064 Spare part: Viton rubber ring for motor cartridge2011-02-14
Humeca, Inc. [Humeca BV]
4,062 Spare part: dermatome motor Amax 32 (only motor, no ca2011-02-14
Humeca, Inc. [Humeca BV]
4,061 Spare part: microswitch2011-02-14
Humeca, Inc. [Humeca BV]
4,059 Spare part: Power switch support (window) with screws2011-02-14
Humeca, Inc. [Humeca BV]
4,058 Spare part: Power switch + 2x M2x4 screws2011-02-14
Humeca, Inc. [Humeca BV]
4,053 Spare part: dermatome lever2011-02-14
Humeca, Inc. [Humeca BV]
4,033 Spare part: motor cartridge metal tube (tube only, not2011-02-14
Humeca, Inc. [Humeca BV]
4,017 Spare part: closing cap Li-Ion2011-02-14
Humeca, Inc. [Humeca BV]
4,016 Spare part: D80 covering plate, stainless steel2011-02-14
Humeca, Inc. [Humeca BV]
4,015 Spare part: D42 covering plate, stainless steel2011-02-14
Humeca, Inc. [Humeca BV]
4,014 Spare part: closing cap Ni-MH2011-02-14
Humeca, Inc. [Humeca BV]
4,009 Spare part: D42 blade cover2011-02-14
Humeca, Inc. [Humeca BV]
4,008 Spare part: D80 blade cover2011-02-14
Humeca, Inc. [Humeca BV]
3.SW01 MEEK serrated wedge (cam)2011-02-14
Humeca, Inc. [Humeca BV]
3.SHD MEEK hand drive set, block version (compatible with pn2011-02-14
Humeca, Inc. [Humeca BV]
3.RM004 MEEK pneumatic block motor with connectors and coupl2011-02-14
Humeca, Inc. [Humeca BV]
3.MD/GW MEEK cutting machine, motor driven, gearwheels, with2011-02-14
Humeca, Inc. [Humeca BV]
3.MD/AUT MEEK cutting machine, automatic, without block2011-02-14
Humeca, Inc. [Humeca BV]
3.MD MEEK cutting machine, motor driven, without cutti2011-02-14
Humeca, Inc. [Humeca BV]
3.MD Humeca Micrograft gauze, expansion 1:6, with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
3.MAC03 MEEK autoclave case for blades axis2011-02-14
Humeca, Inc. [Humeca BV]
3.MAC02 MEEK sterilization case 434x254x172 mm2011-02-14
Humeca, Inc. [Humeca BV]
3.MAC01 MEEK sterilization case 620x260x107 mm2011-02-14
Humeca, Inc. [Humeca BV]
3.KN13/38 MEEK cutting axis with 13 ceramic coated circular2011-02-14
Humeca, Inc. [Humeca BV]
3.HD/CYL MEEK cutting machine, hand driven (cylindrical mode2011-02-14
Humeca, Inc. [Humeca BV]
3.HD/BLO MEEK cutting machine, hand driven (block model) wit2011-02-14
Humeca, Inc. [Humeca BV]
3.CP4 MEEK pneumatic foot pedal with connectors and hose2011-02-14
Humeca, Inc. [Humeca BV]
3.CH01 MEEK cork holder2011-02-14
Humeca, Inc. [Humeca BV]
3.CB02 MEEK double cutting block with two cork holders2011-02-14
Humeca, Inc. [Humeca BV]
3.CB01 Meeksingle cutting block with cork holder2011-02-14
Humeca, Inc. [Humeca BV]
3.CA01 MEEK cutting aid 41x41 mm.2011-02-14
Humeca, Inc. [Humeca BV]
3.BL38MEEK circular ceramic coated blade, diameter 38 mm.2011-02-14
Humeca, Inc. [Humeca BV]
3.BL38 MEEK circular ceramic coated blade, diameter 38 mm.2011-02-14
Humeca, Inc. [Humeca BV]
2.JG598 STERILIT? oil for surgical instruments, bottle 50 ml2011-02-14
Humeca, Inc. [Humeca BV]
2.9/40 MEEK Micrograft gauze, expansion 1:9, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.9/10PS Mic Gauze, 1:9, with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
2.9/10??Humeca Micrograft gauze, expansion 1:9, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.9/10 MEEK Micrograft gauze, expansion 1:9, with cork pla2011-02-14
Humeca, Inc. [Humeca BV]
2.6/40 MEEK Micrograft gauze, expansion 1:6, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.6/10PS Mic gauze 1:6 with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
2.6/10??Humeca Micrograft gauze, expansion 1:6, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.6/10 MEEK Micrograft gauze, expansion 1:6, with cork pla2011-02-14
Humeca, Inc. [Humeca BV]
2.4/40 MEEK Micrograft gauze, expansion 1:4, with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
2.4/10PS Mic gauze, 1:4 with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
2.4/10???Humeca Micrograft gauze, expansion 1:4, with cork p2011-02-14
Humeca, Inc. [Humeca BV]
2.4/10 MEEK Micrograft gauze, expansion 1:4, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.3/40 MEEK Micrograft gauze, expansion 1:3, with cork pla2011-02-14
Humeca, Inc. [Humeca BV]
2.3/10??Humeca Micrograft gauze, expansion 1:3, with cork pl2011-02-14
Humeca, Inc. [Humeca BV]
2.3/10 PS Mic gauze, 1:3 with cork plate2011-02-14
Humeca, Inc. [Humeca BV]
2.3/10 MEEK Micrograft gauze, expansion 1:3, with cork pla2011-02-14
Humeca, Inc. [Humeca BV]
2.2/10 MEEK Micrograft gauze, expansion 1:2, with cork plate, box 10 pcs.2011-02-14
Humeca, Inc. [Humeca BV]
6.v10-2.0PS V-carr. 1:2 Humeca and Zimmer mesher 5 per2011-02-14
Humeca, Inc. [Humeca BV]
6.V5-1.0 PS V-carr. 1:1 Humeca and Zimmer mesher2011-02-14
Humeca, Inc. [Humeca BV]
6.V10.1.0 PS V carr. !:1 Humeca and Zimmer mesher 5 carriers2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-3.0PS V-Carr. 1:3 Humeca and Zimmer mesher 5 per2011-02-14
Humeca, Inc. [Humeca BV]
6.V10-1.5PS V-Carr 1-1.5 Humeca and Zimmer mesher 5 per2011-02-14
Humeca, Inc. [Humeca BV]
6.KN50/36 Cutting axis, containing 50 blades ? 36 mm2011-02-14
Humeca, Inc. [Humeca BV]
6.HMAC02 Autoclave case for the cutting axis of the Humeca?2011-02-14
Humeca, Inc. [Humeca BV]
6.HMAC01 Autoclave case for Humeca? mesher2011-02-14
Humeca, Inc. [Humeca BV]
6.HM01 Humeca? mesher2011-02-14
Humeca, Inc. [Humeca BV]
6,204 Circular blade, ? 36 mm for Humeca mesher2011-02-14

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