BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALLWIN MEDICAL DEVICES, INC.

    Reg #: 3005987240 · FEI: 3005987240 · Expires 2026
    View on FDA
    Products
    60
    Proprietary Names
    298
    Establishment Types
    3
    Classifications
    60

    Registration Details

    Registration Name
    ALLWIN MEDICAL DEVICES, INC.
    Registration Number
    3005987240
    FEI Number
    3005987240
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3305 E. MIRALOMA AVENUE, SUITE 176
    City
    ANAHEIM
    State
    CA
    ZIP
    92806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200248

    Owner / Operator

    Firm Name
    ALLWIN MEDICAL DEVICES, INC.
    Operator Number
    9094082
    Address
    3305 E. Miraloma Ave, SUITE176
    City
    Anaheim
    State
    CA
    Postal Code
    92806
    Country
    US
    Correspondent
    Digish D Mehta

    Products

    Device Name Product Code
    Catheter, Assisted Reproduction MQF
    Catheter, Hemodialysis, Implanted MSD
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Endoscopic Bite Block MNK
    Evacuator, Gastro-Urology KQT
    Stylet For Catheter, Gastro-Urology EZB
    Catheter, Femoral LFK
    Needle, Assisted Reproduction MQE
    Catheter, Nephrostomy LJE
    Dilator, Catheter, Ureteral EZN
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Stylet, Ureteral EYA
    Needle, Aspiration And Injection, Reusable GDM
    Ligator, Hemorrhoidal FHN
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Cannula, Manipulator/Injector, Uterine LKF
    Dislodger, Stone, Flexible FGO
    Endoscopic Cytology Brush FDX
    Clamp, Penile FHA
    Catheter, Suprapubic (And Accessories) KOB
    Prosthesis, Esophageal ESW
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Needle, Aspiration And Injection, Disposable GAA
    Syringe, Irrigating (Non Dental) KYZ
    Evacuator, Bladder, Manually Operated FFD
    Lithotriptor, Electro-Hydraulic FFK
    Table, Obstetrical, Ac-Powered (And Accessories) HDD
    Catheter, Urological KOD
    Tubes, Gastrointestinal (And Accessories) KNT
    Curette, Suction, Endometrial (And Accessories) HHK
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Trocar, Gastro-Urology FBQ
    Cannula, Intrauterine Insemination MFD
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Accessories, Cleaning, For Endoscope FEB
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Forceps, Biopsy, Non-Electric FCL
    Dislodger, Stone, Biliary LQR
    Stent, Ureteral FAD
    Needle, Biopsy, Cardiovascular DWO
    Forceps HTD
    Dilator, Catheter GCC
    Uroflowmeter EXY
    Dilator, Cervical, Fixed Size HDQ
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Instrument, Manual, Specialized Obstetric-Gynecologic KNA
    Aspirator, Endometrial HFF
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Labware, Assisted Reproduction MQK
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Mesh, Surgical, Polymeric FTL
    Catheter, Ureteral, General & Plastic Surgery GBL
    Dilator, Urethral KOE
    Spatula, Cervical, Cytological HHT
    Catheter, Peritoneal Dialysis, Single Use FKO
    Bronchoscope (Flexible Or Rigid) EOQ
    Micromanipulators And Microinjectors, Assisted Reproduction MQJ
    Lithotriptor, Biliary Mechanical LQC
    Snare, Flexible FDI
    Accessories, Blood Circuit, Hemodialysis KOC

    Proprietary Names

    Pro Echo Trans Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter Bulb Trans Ultra Embryo Transfer Catheter Soft Obturator for Twinkle Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Echo Trans 23cm Trial Transfer Catheter for Echo Trans 18cm Twinkle Embryo Trans Embryo Transfer Catheter 18cm Embryo Trans Embryo Transfer Catheter 18cm Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Embryo Trans 23cm Bulb Trans Star Embryo Transfer Catheter Soft Obturator for Pro Echo Trans Embryo Transfer Catheter ECHO TRANS Embryo Transfer Catheter 18cm Soft Obturator for Pro Embryo Trans Embryo Transfer Catheter Trial Transfer Catheter for Twinkle Embryo Trans 18cm Trial Transfer Catheter for Embryo Trans 18cm Trial Transfer Catheter for Twinkle Embryo Trans 23cm PRO-PASS STAR Embryo Transfer Catheter with STYLET PRO-PASS STAR Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter with Stylet PRO-PASS TWINKLE Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter PRO-PASS STAR Embryo Transfer Catheter with soft obturator PRO-PASS Embryo Transfer Catheter with Stylet Trial Transfer Catheter for Pro-Pass Star Embryo Transfer Catheter Stylet for Pro-Pass Embryo Transfer Catheter Stylet for Pro-Pass Twinkle Embryo Transfer Catheter PRO-PASS ECHO TRANS Embryo Transfer Catheter with Soft Obturator Stylet for Twinkle Embryo Trans Embryo Transfer Catheter 18cm Trial Transfer Catheter for Pro-Pass Twinkle Embryo Transfer Catheter PRO-PASS TWINKLE Embryo Transfer Catheter with Stylet Pro Embryo Trans Embryo Transfer Catheter with Stylet Bulb Trans Star Plus Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Stylet E CATH Embryo Transfer Catheter 18cm SPARKLE VIEW Embryo Transfer Catheter 23cm Stylet for Bulb Trans Ultra Embryo Transfer Catheter PRO ECHO TRANS Embryo Transfer Catheter with Stylet E CATH Embryo Transfer Catheter 23cm LOTUS ULTRA Embryo Transfer Catheter- Bulb Tip Stylet for Pro Echo Trans Embryo Transfer Catheter Stylet for Echo Trans Embryo Transfer Catheter 18cm PRO ECHO TRANS Embryo Transfer Catheter with Soft Obturator Embryo Trans Embryo Transfer Catheter 23cm Soft Obturator for Pro-Pass Embryo Transfer Catheter LOTUS STAR Embryo Transfer Catheter- Bulb Tip Soft Obturator for Pro-Pass Star Embryo Transfer Catheter SPARKLE VIEW Embryo Transfer Catheter 18cm PROCATH Embryo Transfer Catheter Stylet for Embryo Trans Embryo Transfer Catheter 18cm Stylet for Introducing Catheter with Outer Sheath 18cm ECHO VIEW Embryo Transfer Catheter 23cm PRO-PASS Embryo Transfer Catheter Stylet for Twinkle Pro Embryo Trans Embryo Transfer Catheter Stylet for Twinkle Embryo Trans Embryo Transfer Catheter 23cm PRO ECHO VIEW Embryo Transfer Catheter PRO-PASS Embryo Transfer Catheter with Soft Obturator PRO-PASS TWINKLE Embryo Transfer Catheter with Soft Obturator Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator SPARKLE PRO VIEW Embryo Transfer Catheter ECHO VIEW Embryo Transfer Catheter 18cm ECHO TRANS Embryo Transfer Catheter 23cm Soft Obturator for Pro-Pass Twinkle Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator Stylet for Pro-Pass Star Embryo Transfer Catheter Stylet for Pro Embryo Trans Embryo Transfer Catheter Stylet for Echo Trans Embryo Transfer Catheter 23cm Stylet for Embryo Trans Embryo Transfer Catheter 23cm Bulb Trans Ultra Plus Embryo Transfer Catheter Trial Transfer Catheter for Pro-Pass Embryo Transfer Catheter Twinkle Embryo Trans Embryo Transfer Catheter 23cm Stylet for Bulb Trans Star Embryo Transfer Catheter Stylet for Introducing Catheter with Outer Sheath 23cm Flexi-Cath Dual Lumen Catheter ULTIMA Direct Puncture Drainage Set Percutaneous Nephrostomy Drainage Set - ULTIMA Percutaneous Nephrostomy Drainage Set - Pigtail Re-Entry Malecot Catheter Percutaneous Nephrostomy Drainage Set - Malecot Percutaneous Nephrostomy Catheter - Malecot Percutaneous Nephrostomy Catheter - ULTIMA Percutaneous Nephrostomy Catheter - Pigtail Bite-O Bite Block Tur-Vac Bladder Evacuator Ellick Bladder Evacuator - Glass Ellick Bladder Evacuator - Plastic SCHULLER Guidewire HYGUIDE Hydrophilic Guidewire LUNDERQUIST Guidewire COBRA Nitinol Guidewire KING COBRA Nitinol Guidewire Standard J Tip Guidewire SUPREMO Nitinol Hydrophilic Guidewire Standard Straight Tip Guidewire Femo Cath - Femoral Catheter ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line 16G, 17G, 18G OVUMPICK Double Lumen Ovum Pickup Needle 16G, 17G ACE Single Lumen Ovum Pickup Needle 16G, 17G, 18G ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 17G, 18G Eagle Single Lumen Ovum Pickup Needle 17G EAGLE-FL Single Lumen Ovum Pickup Needles with Flushing Line DUALFLOW Double Lumen Ovum Pickup Needle 17G EAGLE-M Manual Single Lumen Ovum Pickup Needle ASPI Aspiration Needle 18G, 22G FALCON Single Lumen Ovum Pickup Needle 17G OPICK Double Lumen Ovum Pickup Needle ARMADA Ureteral Dilator Set ARMADA Amplatz Renal Dilator Set ARMADA Nottingham One Step Dilator Fascial Dilator Introducer Catheter Glider Amplatz Sheath Introducer Sheath ARMADA Renal Dilator URE-FLOW Irrigator TRACKFINDER Bulb Irrigator GUIDEWIRE BLN SURGI BAND - Multiple Ligator SURGI BAND - Multiple Ligator Kit U-FLEX DUO Ureteral Access Sheath U-FLEX Ureteral Access Sheath SALPINX CATH - Fallopian Tube Recanalisation And Set HYSTERO CATH - Hystero Salpinogography Catheter and Set Retrieval Basket Retrieval Snare Retrieval Forceps Cytology Brush CONTISTRAP Male Incontinence Clamp Suprapubic Puncture Set Suprapubic Drainage Set Esopha - Esophageal Stent Majestick Biliary Stent Introducer Bilo - Biliary Stent System Percutaneous Transhepatic Cholangio Naso Pancreatic Draiange Catheter PAN Stents - Pancreatic Stent Stone Extraction Balloon Naso Biliary Drainage Catheter Biliary Stent Bilo Biliary Stent Biliary Dilatation Catheter Biliary Stent Double Pigtail Biliary Stent Standard PTFE Chiba Needle Initial Puncture Needle Injection Needle TLA Introducer Needle Breast Localization Needle Tur Vac Bladder Evacuator with Adaptor - TV Ellick Bladder Evacuator StoneBuster Pneumatic Lithotripter Track OS Cervical OS Dilator Pediatric Urethral Stent Nova Urethral Stent UTOB - Urinary Track Occlusion Balloon Nasal Jejunal Feeding Tube Endoscopic Nasal Jejunal Feeding Tube RGT - Replacement Gastrostomy Tube SURGI PEG - Percutaneous Endoscopic Gastronomy Tube THE SAMPLER - Endometrial Biopsy Catheter PRO-VAC Endometrial Biopsy Catheter Surgiject - Injection Needle SCN - Sclerotherapy Needle SupraSet DPD Suprapubic Metal Tip Puncture and Drainage Set Suprapubic Puncture and Drainage Set Loop Supra Set INSEMINA - Intra Uterine Insemination Catheter STUMPY - Intra Uterine Insemination Catheter CURVED - Intra Uterine Insemination Catheter TRACKABLE - Intra Uterine Insemination Catheter FLEXI - Intra Uterine Insemination Catheter CURVED Open Tip - Intra Uterine Insemination Catheter INSEMINA Open Tip - Intra Uterine Insemination Catheter FLEXI Open Tip - Intra Uterine Insemination Catheter TRACKABLE Open Tip - Intra Uterine Insemination Catheter Small Bowel Enema Catheter Decompression Tube Reusable Cleaning Brush Dispo Brush Injection Cap MaxiBite Biopsy Forcep Stent Remover Helical Stone Extractor Multiwire Stone Extractor Pediatric Ureteral Stent Open Tip Ureteral Stent Open Tip Ureteral Stent Closed Tip Mono J Urinary Diversion Ureteral Stent Open Tip Ureteral Stent Via Ureterorenoscope Closed Tip Pediatric Ureteral Stent Closed Tip Multiloop Ureteral Stent Closed Tip Mono J Urinary Diversion Ureteral Stent Closed Tip Multiloop Ureteral Stent Open Tip Ureteral Stent Via Ureterorenoscope Open Tip Ureteral Stent Intraoperative Tip NephroTrack Balloon Dilator Uretrack Ureteral Balloon Dilator TU Transuretroscopic Balloon Dilator NephroTrack Balloon Dilator with Sheath NEEDLES BIOPSY Autocore Biospy Needle Pronto Biopsy Needle Ultracore Biopsy Needle Speedo Automatic Biopy Needle Stent Remover Snare Pull-It Stent Remover Renal Dilator with Amplatz Sheath Renal Dilator Amplatz Renal Dilator Set Amplatz Sheath INSEMINA Intra Uterine Insemination Catheter Open Tip FLEXI Intra Uterine Insemination Catheter Open Tip FLEXI Intra Uterine Insemination Catheter INSEMINA Intra Uterine Insemination Catheter CURVED Intra Uterine Insemination Catheter Open Tip Curved STUMPY Intra Uterine Insemination Cannula TRACKABLE Intra Uterine Insemination Catheter Open Tip with Malleable Stylet TRACKABLE Intra Uterine Insemination Catheter with Malleable Stylet CURVED Intra Uterine Insemination Catheter Curved IUI-M Intra Uterine Insemination Catheter with Malleable Stylet INTEGRA Intra Uterine Insemination Catheter IUI SHORTY Intra Uterine Insemination Cannula Shorty IUI-C Intra Uterine Insemination Catheter Curved Uriflow - Uroflowmeter Cervical OS Dilator Urine Bag Connector Ectocervical & Endocervical Samplin Endocervical Sampling Brush Sonohysterography Uterine Catheter allFlex Ureteral Catheter Rigid Grasping Forcep NITIFLEX Nitinol Stone Basket Stainless Steel Flatwire & Helical Three Prong Grasping Forcep Trapper No Tip Basket Mini - Flatwire & Helical U-Perc Nitinol Stone Extractor Maestro Nitinol Tipless Stone Basket URETERAL STONE BASKET SureLock- Yellow- Vitrification Straws: SUL-Y SureStrip- Ivory- Vitrification Straws: SUS-I SureStrip- Red- Vitrification Straws: SUS-R SureStrip- Yellow- Vitrification Straws: SUS-Y Surestrip- White- Vitrification Straws: SUS-W SureLock Green- Vitrification Straws: SUL-G SureLock - Violet - Vitrification Straws - SUL-V SureLock - Pink - Vitrification Straws -SUL-P SureLock- Blue- Vitrification Straws: SUL-B SureStrip- Blue- Vitrification Straws: SUS-B SureStrip - White - Vitrification Straws - Weighted - SUS-W-WT V-Lock Vitrification Straws- Green- VL-G V-Strip Vitrification Straws- Blue- VS-B V-Lock Vitrification Starws- Yellow- VL-Y SURESTRIP - White - Vitrification Straws -Weighted Plug - SUS-W-WTP V-Strip Vitrification Straws- Red- VS-R V-Lock Vitrification Straws- Pink- VL-P SURESTRIP - Red - Vitrification Straws -Weighted Plug - SUS-R-WTP V-Lock Vitrification Straws- Blue- VL-B SureStrip - Red - Vitrification Straws - Weighted - SUS-R-WT V-Strip Vitrification Straws- White- VS-W SureStrip - Yellow - Vitrification Straws - Weighted - SUS-Y-WT SureStrip -Ivory - Vitrification Straws- Weighted - SUS-I-WT SURESTRIP - Blue - Vitrification Straws -Weighted Plug - SUS-B-WTP V-Strip Vitrification Straws- Ivory- VS-I SureStrip - Blue - Vitrification Straws - Weighted - SUS-B-WT V-Strip Vitrification Straws-Yellow- VS-Y V-Lock Vitrification Straws- Violet- VL-V SURESTRIP - Ivory - Vitrification Straws -Weighted Plug - SUS-I-WTP SURESTRIP - Yellow - Vitrification Straws -Weighted Plug - SUS-Y-WTP AspiPump 90D - ASPI 90D Aspi Hydrophobic Filter Set - ASP-HFS Aspi Suction Line with Luer Lock Connectors - ASP-SL Power Adapter & AC Plug Set - ASP-PA Aspi Foot Switch - ASP-FS Aspi Suction Bottle with Connector - ASP-SB Super Mesh Cobra Catheter Meatal Dilator Adult Inflation Device Advanced Meatal Dilator Pediatric Disposable Inflation Device Wooden Ayre's Spatula Plastic Ayre's Spatula P D Cath Peritoneal Dialysis Cathet Lung Biopsy Needle Allwin D-TIPS 300µm Allwin D-TIPS 130µm Allwin D-TIPS 600µm Allwin D-TIPS 120 µm Allwin D-TIPS 170µm Allwin D-TIPS 275µm Allwin D-TIPS 140µm MECHLITH - Mechanical Lithotripter Toomey Syringe POLYSNARE - Polypectomy Snare Introducer Needle

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device