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) (6) Needle, Assisted Reproduction (MQE) (3) Cannula, Intrauterine Insemination (MFD) (1)

Premarket Exempt

No Yes

Clear

Bulb Trans Star Embryo Transfer Catheter - Bulb Tip - 00819374021289 Catalog Number : BT-ETC-U-S

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

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Stylet for Pro Embryo Trans/ Twinkle Pro Embryo Trans - 00819374021456 Catalog Number : STY-PE

Device Description : Stylet for Pro Embryo Trans/ Twinkle Pro Embryo Trans

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Twinkle Embryo Trans Embryo Transfer Catheter (23cm) - 00819374021524 Catalog Number : TEB-ETC23

Device Description : Twinkle Embryo Trans Embryo Transfer Catheter 23cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Twinkle Pro - 00819374021548 Catalog Number : TPEB-ETC

Device Description : Twinkle Pro Embryo Transfer Catheter

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Twinkle Pro with Stylet - 00819374021753 Catalog Number : TPEB-ETC-STY

Device Description : TWINKLE 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

ACE-FL - 00819374021777 Catalog Number : A-OVM-SL-FL 16/35

Device Description : ACE Single Lumen Ovum Pick-up Needle 16G, 35cm with Flushing Line

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

Insemina Open Tip Intra Uterine Insemination Catheter - 00819374021814 Catalog Number : I-IUI-O

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

ACE-FL - 00819374021821 Catalog Number : A-OVM-SL-FL 18/35

Device Description : ACE Single Lumen Ovum Pick-up Needle 18G, 35cm with Flushing Line

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

OVUMPICK - 00819374021845 Catalog Number : OVM-DL 17/35

Device Description : OVUMPICK Double Lumen Ovum Pickup Needle 17G, 35cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

Twinkle Pro with Soft Obturator - 00819374021852 Catalog Number : TPEB-ETC-SB

Device Description : TWINKLE 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

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