ALLWIN MEDICAL DEVICES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005987240	3005987240	ALLWIN MEDICAL DEVICES, INC.	1	N	2026-01-01	3305 E. MIRALOMA AVENUE SUITE 176 ANAHEIM CA US 92806

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00812261010069	allSoft - allSoft Ureteral Stent Open Tip 5F, 24cm	714-572-1709	info@allwinmedical.com
00812261010823	allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 10cm	714-512-1709	info@allwinmedical.com
00812261010830	allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 12cm	714-512-1709	info@allwinmedical.com
00812261010854	allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 16cm	714-512-1709	info@allwinmedical.com
00812261010861	allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 10cm	714-512-1709	info@allwinmedical.com
00812261016597	ASPI - ASPI Aspiration Needle 22G,30cm	714-572-1709	info@allwinmedical.com
00819374021746	SURESTRIP - SURESTRIP Vitrification Straw - Yellow colour	714-512-1709	info@allwinmedical.com

allwinmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
67447	2045188357	K220781	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	EZN	2023-05-05
67447	1348558823	K220730	allFlex Ureteral Catheters, Krait Ureteral Catheters	KOD	2022-10-13
67447	1702590803	K203626	SureStrip Vitrification Straw, SureLock Vitrification Straw	MQK	2021-06-04
67447	1400279702	K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators	MQF	2020-07-01
67447	1230389898	K190659	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	FAD	2019-12-02
67447	1739908097	K190590	Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)	MQE	2019-11-25
67447	1113753317	K190522	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)	MQF	2019-11-14
67447	1087304312
67447	1705303466
67447	1002738608
67447	1003389241
67447	1035013663
67447	1054416883
67447	1114001364
67447	1137533581
67447	1174943909
67447	1185312902
67447	1226189370
67447	1304453408
67447	1322313401
67447	1327956658
67447	1351232932
67447	1357199033
67447	1395437084
67447	1404631796
67447	1411928461
67447	1478556274
67447	1482170758
67447	1522234485
67447	1531628982
67447	1532429692
67447	1539672240
67447	1549110050
67447	1564455161
67447	1601854287
67447	1612667996
67447	1621901592
67447	1627790151
67447	1629811500
67447	1637902047
67447	1638312689
67447	1647891037
67447	1675209298
67447	1681194925
67447	1687178864
67447	1696759453
67447	1700702969
67447	1708249354
67447	1712507463
67447	1728165665
67447	1753765050
67447	1784666051
67447	1801775055
67447	1808247668
67447	1826628475
67447	1859861801
67447	1913441599
67447	1917709563
67447	1927747861
67447	1964512191
67447	1967004163
67447	1986532690
67447	2014881933
67447	2028640037
67447	2063480733

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MQF	2	2020-07-01
EZN	1	2023-05-05
KOD	1	2022-10-13
MQK	1	2021-06-04
FAD	1	2019-12-02
MQE	1	2019-11-25

PMN#

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
2023-05-05
Allwin Medical Devices, Inc.
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets And Soft Obturators
2020-07-01
Allwin Medical Devices, Inc.
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 T
2019-12-02
Allwin Medical Devices, Inc.
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle With Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
2019-11-25
Allwin Medical Devices, Inc.
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, FLE
2019-11-14
Allwin Medical Devices, Inc.

GUDID#

ASPI - ASPI Aspiration Needle 22G,30cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
SURESTRIP - SURESTRIP Vitrification Straw - Yellow colour
ALLWIN MEDICAL DEVICES, INC.
2024-01-10
allSoft - allSoft Ureteral Stent Open Tip 5F, 24cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 10cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 12cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 14cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 16cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 10cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 14cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 16cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 10cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 12cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 14cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 3F, 16cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 10cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 12cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 14cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Pediatric Ureteral Stents Open Tip 4F, 16cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allDrain - allDrain Percutaneous Nephrostomy Catheter Pigtail- 14F, 30cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 7F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allSoft - allSoft Urinary Diversion Stents [Mono - J] Open Tip 7F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 4.7F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 7F, 70cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 4.7F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 6F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
R+ - R+ Urinary Diversion Stents [Mono - J] Open Tip 7F, 70cm with Guidewire
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allDrain - allDrain Percutaneous Nephrostomy Catheter Pigtail- 9F, 30cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allDrain - allDrain Percutaneous Nephrostomy Catheter Pigtail- 10F, 30cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
SALPINX CATH - SALPINX CATH Fallopian Tube Recanalisation Set with Malleable Stylet
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
allDrain - allDrain Percutaneous Nephrostomy Catheter Pigtail- 12F, 30cm
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
SURELOCK - SURELOCK Vitrification Straw - Pink colour
ALLWIN MEDICAL DEVICES, INC.
2024-01-09
SURELOCK - SURELOCK Vitrification Straw - Yellow colour
ALLWIN MEDICAL DEVICES, INC.
2024-01-09

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