HomeCanadaBIOLAB EQUIPMENT LTD. O/A MAR COR PURIFICATION

BIOLAB EQUIPMENT LTD. O/A MAR COR PURIFICATION

Canada · Burlington
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 1Class III 2
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States0 registration records, 7 510(k), 0 PMA, 3 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: BIOLAB EQUIPMENT LTD. O/A MAR COR PURIFICATION
Same-named companies — This database also contains companies with near-identical names: Mar Cor Purification, Inc., Mar Cor Services, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Burlington

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 510(k) clearances by year

11996 · K945559
22001 · K003877
12011 · K110578
12014 · K133149
12019 · K192398
12020 · K200670

Registration details (sample)

MarketIdentifierNameClass / date
USK200670EON Portable RO Water Purification System2020-04-16
USK192398Millenium HX2019-10-03
USK133149BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM2014-04-30
CA64434BIOPURE SERIES 8400 WATER PURIFICATION SYSTEMClass III
CA660294100 M (HOT WATER - SANITIZATION SYSTEM)Class II
CA68359SEMPER PURE REVERSE OSMOSIS SYSTEMClass III

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