MALEM MEDICAL LIMITED

MALEM MEDICAL LIMITED

Address:10 WILLOW HOLT,NOTTINGHAM Nottinghamshire,GB

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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) (9) Massager, Therapeutic, Electric (ISA) (1)

Premarket Exempt

Yes

Clear

Malem - 05060049630038 Catalog Number :

Device Description : Malem Audio (MO3) enuresis alarm (sound 1, red)

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630045 Catalog Number :

Device Description : Malem Ultimate (MO4) enuresis alarm (8-tone, gold)

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630052 Catalog Number :

Device Description : Malem Ultimate 1+ Record (MO5) enuresis alarm (red)

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630069 Catalog Number :

Device Description : Malem Bed-Side (MO6) enuresis alarm

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630076 Catalog Number :

Device Description : Malem Wireless (MO7) enuresis alarm

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630120 Catalog Number :

Device Description : Malem Ultimate Selectable (MO4S) enuresis alarm (royal blue)

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630144 Catalog Number :

Device Description : Queen's Square Bladder Stimulator - Selectable (PC9S)

Device Class : 1

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Malem - 05060049630151 Catalog Number :

Device Description : Malem Wireless (MO12) enuresis alarm

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630168 Catalog Number :

Device Description : Malem Universal Wireless (MO15) enuresis alarm

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

Malem - 05060049630182 Catalog Number :

Device Description : Malem Ultimate Multi-Choice (MO17) enuresis alarm

Device Class : 2

Duns Number: 291490076

Premarket Exempt : Yes

Product Code : KPN

Prescription Use : No

Device Count : 1

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