Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008950755

FEI Number

3008950755

Entity Name

HUMECA BV

City/State/Country

Borne Overijssel, NL

Establishment Address

Oostermaat 5, Borne Overijssel 7623 CS, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Humeca BV (Owner Number: 10035227)

Owner / Operator Contact Address

Oostermaat 5, Borne, NL-NOTA 7623 CS, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-02-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-11-28
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-28
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2011-02-14

Official Correspondent

Johannes Van Velzen

US Agent Details

Kenneth Kleinhenz Business: QSR Consulting Email: kleinhenz64@gmail.com Phone: (619) 2449573

Related Public Records

Same Entity

Humeca BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012366928	Humeca, Inc.	Miami Shores, FL, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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3023809973	RUSUN MEDICAL CO., LTD	Yichun City Jiangxi, CN
3008496217	DERMATO PLASTICA BEAUTY CO., LTD.	Kaohsiung City, TW
3001614464	medi-G GMBH	Messkirch Baden-Wurttemberg, DE
3028006458	ClearPoint Neuro Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008950755. Last updated year: 2026. Please use registration number 3008950755 when referencing this establishment in official correspondence.