SIMAVITA (AUST) PTY LTD

SIMAVITA (AUST) PTY LTD

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Alarm, Conditioned Response Enuresis (KPN) (10)

Premarket Exempt

No

Clear

SIM pants Regular - 09342124000179 Catalog Number :

Device Class :

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 3

SIM pod kit - 09342124000285 Catalog Number :

Device Description : ANZ specific SIM pod kit containing:- 1 SIM pod- 1 SIM dock- 1 power supply with ANZ specific SIM pod kit containing:- 1 SIM pod- 1 SIM dock- 1 power supply with ANZ adaptor

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM pod kit - 09342124000292 Catalog Number :

Device Description : NA specific SIM pod kit containing:- 1 SIM pod- 1 SIM dock- 1 power supply with NA adaptor

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM pod kit - 09342124000308 Catalog Number :

Device Description : EU specific SIM pod kit containing:- 1 SIM pod- 1 SIM dock- 1 power supply with EU adaptor

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM sensor LIGHT kit - 09342124000315 Catalog Number :

Device Description : SIM sensor LIGHT kit which contains:- 30 x SIM sensor LIGHT- 9 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM sensor MODERATE kit - 09342124000322 Catalog Number :

Device Description : SIM sensor MODERATE kit which contains:- 20 x SIM sensor MODERATE;- 6 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM sensor HEAVY kit - 09342124000339 Catalog Number :

Device Description : SIM sensor HEAVY kit which contains:- 20 x SIM sensor HEAVY;- 6 x SIM pants REGULAR

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM™ pod - 09342124000346 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM™ dock - 09342124000353 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

SIM sensor Light - 09342124000360 Catalog Number :

Device Class : 2

Duns Number: 757459958

Premarket Exempt : No

Product Code : KPN

Prescription Use : No

Device Count : 1

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