HomeSouth AfricaPhoton Therapy Systems (Pty) Ltd

Photon Therapy Systems (Pty) Ltd

South Africa · Pretoria · www.photizo.net
✓ Record-verifiedregistrations found in 3 marketsEU SRN ZA-MF-000037447

This company has registrations in European Union, United States, United Kingdom — 3 overseas markets. EU UDI-DI records ≥8, 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
≥8UDI-DI device records
Class IIa 8
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 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 Union558 raw hits, 292 excluded, 8 confirmed. Large result set — only the first 300 verified
United States1 registration records, 0 510(k), 0 PMA, 4 excluded
United Kingdom1 confirmed, 12 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: PHOTON THERAPY SYSTEMS (PTY) LTD

Regulatory identity

EU manufacturer SRN
ZA-MF-000037447
EU authorised representative
TNMC Devices Llc
UK responsible person
TNMC Medical Devices Ltd

Company information

Country
South Africa
City
Pretoria
Website
www.photizo.net
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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

Lamp, Infrared, Therapeutic Heating 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06009900149189Class IIa
EU06009900149134Class IIa
EU06009900149110Class IIa
EU06009900149141Class IIa
UK62202PhotizoClass IIa

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