Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Netherlands›Humeca, Inc.

Humeca, Inc.

Netherlands · Borne Overijssel
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 6Class II 0Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 2IIa 2Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 0 510(k), 0 PMA
Brazil0 confirmed, 1 excluded
Saudi Arabia4 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: HUMECA BV · Humeca, Inc. · Humeca BV

Company information

Country
Netherlands
City
Borne Overijssel

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Knife, Surgical 1Instrument, Manual, Surgical, General Use 1Blade, Scalpel 1Tray, Surgical, Instrument 1Cutter, Surgical 1Dermatome 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000011877SFDAA00007MEEK set hand driven complete—
SAME0000011877SFDAA00008MEEK set machine driven complete—

Similar companies

Advantech Europe B.V.
Netherlands · markets 2
ASO Europe B.V.
Netherlands · markets 2
ATRO Medical BV
Netherlands · markets 0
Axxicon BV
Netherlands · markets 0
BAP Medical B.V. SKIN - SCAR - NOSE - WOUND
Netherlands · markets 1
Bondus BV
Netherlands · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →