NightBalance Holding B.V.

NightBalance Holding B.V.

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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

Pillow, cervical (for mild sleep apnea) (MYB) (2)

Premarket Exempt

No

Clear

Lunoa - 08719689344504 Catalog Number : L1US01US

Device Description : Lunoa Sleep Position Trainer, US

Device Class : 2

Duns Number: 489925212

Premarket Exempt : No

Product Code : MYB

Prescription Use : Yes

Device Count : 1

Lunoa - 08719689344511 Catalog Number : L1CHST01

Device Description : Lunoa Chest Strap

Device Class : 2

Duns Number: 489925212

Premarket Exempt : No

Product Code : MYB

Prescription Use : Yes

Device Count : 1

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