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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 (176)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Chiba Needle - 2 Part Bevel Tip	CH-22-20-2	EUDAMED	Class IIa	Active
Guidewire	SHSG150-35	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	RM20-U	EUDAMED	Class IIa	Active
U-Flex Ureteral Access Sheath	00819374021609	EUDAMED	Class I	Active
UltraDrain Suprapubic Puncture Set	SPS16	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	TNB4W/4F-90	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	TNB4W/3F-120	EUDAMED	Class IIa	Active
UltraDrain Suprapubic Puncture Set	SPS12	EUDAMED	Class IIa	Active
Chiba Needle - 2 Part Bevel Tip	CH-18-20-2	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	U040203	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	NITI4W/3F-120-F	EUDAMED	Class IIa	Active
Guidewire	CGS150-35	EUDAMED	Class IIa	Active
Guidewire	LQJ100-35-3	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	PDS-P10	EUDAMED	Class IIa	Active
Guidewire	CGS450-35	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	TNB4W/4F-120	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	M-TNB 4W/1.8F-120	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	U-P8/38	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	PCN-M12	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	PDS-P12	EUDAMED	Class IIa	Active
U-Flex Ureteral Access Sheath	UF14/12-38	EUDAMED	Class I	Active
Initial Puncture Needle - 3 Part Bevel Tip	IPN-18-20-3	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	PDS-P8	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	SF4W/3F-120-F	EUDAMED	Class IIa	Active
Guidewire	HGSF150-35	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	TNB4W/2.4F-120	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	PCN-M14	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	SF4W/3F-90-F	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	U-DPD-12/30	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	RM18-U	EUDAMED	Class IIa	Active
Guidewire	SFT150-35	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	GF3W/3F-120	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	ESR1.9/120/10	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	UBC	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	SB4W/3F-90-H	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	TNB4W/2.4F-90	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	NITI4W/3F-90-F	EUDAMED	Class IIa	Active
Chiba Needle - 2 Part Bevel Tip	CH-20-20-2	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	U-DPD-8/30	EUDAMED	Class IIa	Active
Drainage Catheter & Sets	U-DPD-10/30	EUDAMED	Class IIa	Active
Stone Baskets & Extractors	GF3W/3F-90	EUDAMED	Class IIa	Active
allSoft	allSoft Pediatric Ureteral Stents Open Tip 3F, 16cm	FDA UDI	Class II	Active
allSoft	allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm with Guidewire	FDA UDI	Class II	Active
Surelock	SURELOCK Vitrification Straw	EUDAMEDFDA UDI	Class II	Active
R+	R+ Urinary Diversion Stents [Mono - J] Open Tip 4.7F, 70cm	FDA UDI	Class II	Active
Surelock	SURELOCK Vitrification Straw	EUDAMEDFDA UDI	Class II	Active
allSoft	allSoft Pediatric Ureteral Stents Open Tip 4F, 14cm with Guidewire	FDA UDI	Class II	Active
All Soft Ureteral Stent - 6F, 26cm	Ureteral Stent - 6F, 26cm	FDA UDI	Class II	Active
allDrain	allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm	FDA UDI	Class I	Active
allSoft	allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm	FDA UDI	Class II	Active

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