Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012366928

FEI Number

3012366928

Entity Name

Humeca, Inc.

City/State/Country

Miami Shores, FL, US

Establishment Address

9822 NE 2nd Ave Suite 7, Miami Shores, FL 33138, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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 Humby Knife Humeca Watson Knife Humeca Silver Knife Humeca Cobbett Knife Humeca Humby Long Knife 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 MAX Mesher Humeca® mesher

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-28
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
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-02-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3008950755	HUMECA BV	Borne Overijssel, NL

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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2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
1720747	SONTEC INSTRUMENTS, INC.	CENTENNIAL, CO, US
3032391	Medline ReNewal	Redmond, OR, US
3011625373	METRO MEDICAL	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012366928. Last updated year: 2026. Please use registration number 3012366928 when referencing this establishment in official correspondence.