EnviteC-Wismar GmbH

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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

Oximeter (DQA) (8) Oximeter, Ear (DPZ) (1) Transducer, Gas Pressure, Differential (BYR) (1)

Premarket Exempt

No Yes

Clear

SoftTip® medium - 04036616010016 Catalog Number : 1002211

Device Description : SoftTip® medium RM-3212-9 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® small - 04036616010023 Catalog Number : 1002212

Device Description : SoftTip® small RS-3212-9 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Ear Sensor - 04036616010030 Catalog Number : 1002213

Device Description : Ear Sensor ES-3212-9 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

FingerClip - 04036616010047 Catalog Number : 1002214

Device Description : FingerClip F-3212-9 MySign®

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Disposable Sensor - 04036616010054 Catalog Number : 1002215

Device Description : Disposable Sensor DA-2211-1 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Disposable Sensor - 04036616010061 Catalog Number : 1002216

Device Description : Disposable Sensor DP-2211-2 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MySign® S - 04036616010078 Catalog Number : 1002217

Device Description : MySign® S incl. R-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MySign® S - 04036616010085 Catalog Number : 1002218

Device Description : MySign® S inkl. DA-2211-1 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

MySign® S - 04036616010092 Catalog Number : 1002219

Device Description : MySign® S incl. F-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Flow sensor - 04036616010191 Catalog Number : 1000554

Device Description : Flow sensor SpiroQuant H 3m

Device Class : 1

Duns Number: 330943838

Premarket Exempt : Yes

Product Code : BYR

Prescription Use : Yes

Device Count : 1

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