HomeAustraliaDemax Medical Australia Pty Ltd

Demax Medical Australia Pty Ltd

Australia · Sydney Brookvale NSW · www.demaxmedical.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN AU-MF-000002276

This company has registrations in European Union, United Kingdom — 2 overseas markets. EU UDI-DI records ≥72, the first 300 verified individually. 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
≥72UDI-DI device records
Class I 32Class IIa 40
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
9registered device records
Class I 4Class IIa 3Class IIb 1IVD C 1
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
0active device licences
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.

European Union1,575 raw hits, 228 excluded, 72 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
United Kingdom9 confirmed, 2 excluded
Brazil0 confirmed, 3 excluded

Regulatory identity

EU manufacturer SRN
AU-MF-000002276
EU authorised representative
COOK MEDICAL EUROPE LIMITED
UK responsible person
MDSS-UK RP LIMITED

Company information

Country
Australia
City
Sydney Brookvale NSW
Website
www.demaxmedical.com
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)General Product Development, Development & Design Transfer

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.

Business registration

ABN
55165401570
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2100

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

MarketIdentifierNameClass / date
EU00827002444294MINC+Class IIa
EU00827002200791MINC Class IIa
EU00827002386099Class IIa
EU00827002266834Class IIa
UK45606DP-Tx Bra Insert Class I
UK16784Patient Administration SetClass IIa
UK66775TechnegasPlus Technegas GeneratorClass IIb

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