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ALLWIN MEDICAL DEVICES, INC.

United States·US-MF-000011349

Last updated September 17, 2026

Information

Country: United States
Address: 3305 E Miraloma Ave, Ste 176 Anaheim, CA, United States
Website: www.allwinmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Rakhee Oza
EUDAMED SRN: US-MF-000011349
FDA FEI Number: 3005987240
DUNS Number: —

Catalogue (177)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Meatal Dilator Adult	MDA	FDA UDI	Class II	Active
allDrain	allDrain Percutaneous Nephrostomy Catheter Pigtail- 10F, 30cm	FDA UDI	Class I	Active
Soft Obturator for Twinkle Pro Embryo Trans	Soft Obturator for Twinkle Pro Embryo Trans	FDA UDI	Class II	Active
allSoft	allSoft Pediatric Ureteral Stents Open Tip 4F, 14cm	FDA UDI	Class II	Active
allDrain	allDrain Percutaneous Nephrostomy Catheter Pigtail- 7F, 30cm	FDA UDI	Class I	Active
R+	R+ Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm with Guidewire	FDA UDI	Class II	Active
R+	R+ Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm with Guidewire	FDA UDI	Class II	Active
allDrain	allDrain Percutaneous Nephrostomy Catheter Pigtail- 14F, 30cm	FDA UDI	Class I	Active
allSoft	allSoft Urinary Diversion Stents [Mono - J] Open Tip 7F, 70cm with Guidewire	FDA UDI	Class II	Active
Aspi	ASPI Aspiration Needle	EUDAMEDFDA UDI	Class II	Active
allSoft	allSoft Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm	FDA UDI	Class II	Active
EAGLE Ovum Pickup Needle	E-OVM-SL18/35	EUDAMED	Class IIa	Active
NephroTrack Nephrostomy Track Balloon Dilator	NT10/12-IDA	EUDAMED	Class IIa	Active
UreTrack Ureteral Balloon Dilator	UBD5/4	EUDAMED	Class IIa	Active
ACE Ovum Pickup Needle	A-OVM-SL17/30-FL	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	PEB-ETC-STY	EUDAMEDFDA UDI	Class I	Active
UreTrack Ureteral Balloon Dilator	UBD5/10	EUDAMED	Class IIa	Active
ACE Ovum Pickup Needle	A-OVM-SL16/35-FL	EUDAMEDFDA UDI	Class IIa	Active
D-Tip Denudation Pipettes	D-TIP 175μm	EUDAMED	Class IIa	Active
ACE Ovum Pickup Needle	A-OVM-SL16/30-FL	EUDAMED	Class IIa	Active
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter	K220781	EUDAMEDFDA 510(k)	Class II	Active
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)	K190522	FDA 510(k)	Class II	Active
allFlex Ureteral Catheters, Krait Ureteral Catheters	K220730	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip	K190659	FDA 510(k)	Class II	Active
Embryo Transfer Catheter	TPEB-ETC-SB	EUDAMEDFDA UDI	Class I	Active
D-Tip Denudation Pipettes	D-TIP 275μm	EUDAMED	Class IIa	Active
D-Tip Denudation Pipettes	D-TIP 145μm	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	TT-EB-ETC18	EUDAMED	Class I	Active
Embryo Transfer Catheter	TT-ET-ETC18	EUDAMED	Class I	Active
Embryo Transfer Catheter	TT-ET-ETC23	EUDAMED	Class I	Active
EAGLE Ovum Pickup Needle	E-OVM-SL17/35	EUDAMED	Class IIa	Active
ACE Ovum Pickup Needle	A-OVM-SL18/30-FL	EUDAMED	Class IIa	Active
ACE Ovum Pickup Needle	A-OVM-SL17/30-M	EUDAMED	Class IIa	Active
IntraUterine Insemination Catheter	I-IUI	EUDAMEDFDA UDI	Class I	Active
D-Tip Denudation Pipettes	D-TIP 155μm	EUDAMED	Class IIa	Active
SureStrip Vitrification Straw	SUS-B	EUDAMEDFDA UDI	Class IIa	Active
UreTrack Ureteral Balloon Dilator	UBD5/4-IDA	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	TT-EB-ETC23	EUDAMED	Class I	Active
D-Tip Denudation Pipettes	D-TIP 300μm	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	TT-TEB-ETC18	EUDAMED	Class I	Active
ACE Ovum Pickup Needle	A-OVM-SL18/30-M	EUDAMED	Class IIa	Active
OVUMPICK Ovum Pickup Needle	OVM-DL17/30	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	EB-ETC23	EUDAMEDFDA UDI	Class I	Active
ACE Ovum Pickup Needle	A-OVM-SL18/35-FL	EUDAMEDFDA UDI	Class IIa	Active
Embryo Transfer Catheter	TT-TEB-ETC23	EUDAMED	Class I	Active
ACE Ovum Pickup Needle	A-OVM-SL16/30	EUDAMED	Class IIa	Active
Embryo Transfer Catheter	BT-ETC-U-S-P	EUDAMED	Class I	Active
Trackfinder Bulb Irrigator	TF	EUDAMEDFDA UDI	Class I	Active
OVUMPICK Ovum Pickup Needle	OVM-DL16/30	EUDAMED	Class IIa	Active
NephroTrack Nephrostomy Track Balloon Dilator	NTAM10/12	EUDAMED	Class IIa	Active

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