ALLWIN MEDICAL DEVICES, INC.

Address:3305 E. MIRALOMA AVENUE,ANAHEIM,CA,92806,US

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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

Catheter, Assisted Reproduction (MQF) (5) Cannula, Intrauterine Insemination (MFD) (2) Needle, Assisted Reproduction (MQE) (2) Evacuator, Gastro-Urology (KQT) (1)

Premarket Exempt

No Yes

Clear

Flexi Intra Uterine Insemination Catheter - 00812261016825 Catalog Number : F-IUI

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

Bulb Trans Ultra Embryo Transfer Catheter - 00812261016832 Catalog Number : BT-ETC-U

Device Description : Bulb Trans Ultra Embryo Transfer Catheter - Bulb Tip

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Pro Embryo Trans with Soft Obturator - 00812261016849 Catalog Number : PEB-ETC-SB

Device Description : PRO EMBRYO TRANS- Embryo Transfer Catheter with Soft Obturator

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Trackable Intra Uterine Insemination Catheter - 00812261016863 Catalog Number : T-IUI

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

ACE Single Lumen Ovum Pickup Needle - 00812261016870 Catalog Number :

Device Description : Ace Single Lumen Ovum Pickup Needle (17G,35cm)

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

Embryo Trans Embryo Transfer Catheter 23cm - 00812261016894 Catalog Number : EB-ETC23

Device Description : 23cm Catheter

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Tur Vac - 00812261019413 Catalog Number : TV

Device Description : Tur Vac Bladder Evacuator

Device Class : 2

Duns Number: 796354509

Premarket Exempt : Yes

Product Code : KQT

Prescription Use : Yes

Device Count : 1

Pro Embryo Trans with Stylet - 00819374020268 Catalog Number : PEB-ETC-STY

Device Description : PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Pro Embryo Trans - 00819374020572 Catalog Number : PEB-ETC

Device Description : PRO EMBRYO TRANS - Embryo Transfer Catheter

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

ACE-FL - 00819374020589 Catalog Number : A-OVM-SL-FL 17/35

Device Description : ACE Single Lumen Ovum Pick-up Needle 17G 35cm with Flushing Line

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

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