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) (2)

Premarket Exempt

No Yes

Clear

SoftTip® large - 04036616009898 Catalog Number : 1002199

Device Description : SoftTip® large R-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616009904 Catalog Number : 1002200

Device Description : SoftTip® medium RM-3211-31 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® medium - 04036616009911 Catalog Number : 1002201

Device Description : SoftTip® medium RM-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® small - 04036616009928 Catalog Number : 1002202

Device Description : SoftTip® small RS-3211-31 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® small - 04036616009935 Catalog Number : 1002203

Device Description : SoftTip® small RS-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

FingerClip - 04036616009942 Catalog Number : 1002204

Device Description : FingerClip F-3211-31 MySign

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

FingerClip - 04036616009959 Catalog Number : 1002205

Device Description : FingerClip F-3211-12 MySign®

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Ear Sensor - 04036616009966 Catalog Number : 1002206

Device Description : Ear Sensor ES-3211-31 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

Ear Sensor - 04036616009973 Catalog Number : 1002207

Device Description : Ear Sensor ES-3211-12 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DPZ

Prescription Use : Yes

Device Count : 1

SoftTip® large - 04036616010009 Catalog Number : 1002210

Device Description : SoftTip® large R-3212-9 MySign® FDA

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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