Suzhou Yuyue Medical Technology Co., Ltd.

Address:No. 9 Jinfeng Road, Suzhou Science & Technology Town,Suzhou,CN

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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

Ventilator, Non-Continuous (Respirator) (BZD) (10)

Premarket Exempt

Clear

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510244 Catalog Number :

Device Description : YP-01 Nasal Pillows Mask - large, medium, small. All size kit. For single-patient use.

Device Class :

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510510 Catalog Number :

Device Description : YN-02 Nasal Mask - small, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510527 Catalog Number :

Device Description : YN-02 Nasal Mask - medium, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510534 Catalog Number :

Device Description : YN-02 Nasal Mask - large, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510541 Catalog Number :

Device Description : YN-03 Nasal Mask - small, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510558 Catalog Number :

Device Description : YN-03 Nasal Mask - medium, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510565 Catalog Number :

Device Description : YN-03 Nasal Mask - large, for single-patient use.

Device Class :

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510572 Catalog Number :

Device Description : YF-01 Full Face Mask - small, for single-patient use.

Device Class :

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510589 Catalog Number :

Device Description : YF-01 Full Face Mask - medium, for single-patient use.

Device Class : 2

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

YUWELL Sleep Apnea Breathing Therapy Mask - 06922166510596 Catalog Number :

Device Description : YF-01 Full Face Mask - large, for single-patient use.

Device Class :

Duns Number: 421307196

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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