BEUDAMED
    FDA Registration Active 🇮🇳 India

    Allwin Medical Devices Pvt. Ltd.

    Reg #: 9617744 · FEI: 3006279007 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    111
    Establishment Types
    1
    Classifications
    29

    Registration Details

    Registration Name
    Allwin Medical Devices Pvt. Ltd.
    Registration Number
    9617744
    FEI Number
    3006279007
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot No. 223, 230, and 221, Surat Special Economic Zone, Sachin
    City
    Surat Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K190590

    Owner / Operator

    Firm Name
    Allwin Medical Devices
    Operator Number
    9036357
    Address
    53-CD, KANDIVALI INDUSTRIAL ESTATE, CHARKOP, KANDIVALI (W)
    City
    MUMBAI, MAHARASTRA
    State
    IN-NOTA
    Postal Code
    400 104
    Country
    IN
    Correspondent
    Rakhee Oza

    US Agent

    Business Name
    Allwin Medical Devices Inc.
    Contact Name
    Dhiren Mehta
    Address
    3305 E, Miraloma Ave, Suite 176
    City
    Anaheim
    State
    CA
    ZIP
    92806
    Country
    US
    Email
    [email protected]
    Phone
    714 5721709

    Products

    Device Name Product Code
    Dilator, Cervical, Fixed Size HDQ
    Device, Intravascular Catheter Securement KMK
    Needle, Assisted Reproduction MQE
    Trocar, Gastro-Urology FBQ
    Stent, Ureteral FAD
    Labware, Assisted Reproduction MQK
    Ligator, Hemorrhoidal FHN
    Forceps, Biopsy, Non-Electric FCL
    Evacuator, Gastro-Urology KQT
    Forceps HTD
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Stylet For Catheter, Gastro-Urology EZB
    Catheter, Assisted Reproduction MQF
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Syringe, Irrigating (Non Dental) KYZ
    Catheter, Urological KOD
    Needle, Biopsy, Cardiovascular DWO
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Cannula, Intrauterine Insemination MFD
    Clamp, Penile FHA
    Needle, Tumor Localization MIJ
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Device, Percutaneous, Biopsy MJG
    Dilator, Catheter GCC
    Endoscopic Bite Block MNK
    Dilator, Urethral KOE
    Needle, Aspiration And Injection, Disposable GAA
    Lithotriptor, Biliary Mechanical LQC

    Proprietary Names

    TRACK OS CERVICAL OS DILATOR CATHETER FIXING DISK Eagle-M Manual Single Lumen Ovum Pick Up Needle Eagle-FL Single Lumen Ovum Pick Up Needle with Flushing Line Eagle Single Lumen Ovum Pick-up Needle OPICK Double Lumen Ovum Pick Up Needle Aspiration Needle ASPI Suprapubic Puncture and Drainage Set Suprapubic Metal Tip Puncture and Drainage Set allSoft Multiloop Ureteral Stents R+ Pediatric Ureteral Stents R+ Ureteral Stents (Open Tip, Closed Tip) R+ Multiloop Ureteral Stents allSoft Ureteral Stents (Open Tip, Closed Tip) allSoft Pediatric Ureteral Stents SUL-Y - Yellow SUS-Y - Yellow SUL-V - Violet SUL- P - Pink SUS-I - Ivory SUS-B - Blue SUS-W - White SUS-R-WT - Red Weighted SUS-R - Red SUL-B - Blue SUL-G - Green SURGI BAND - Multiple Ligator SURGI BAND - Multiple Ligator Kit Stent Remover Ellick Bladder Evacuator - Plastic TUR-VAC Bladder Evacuator ELLICK Bladder Evacuator - Glass ELLIK BLADDER EVACUATOR Pull It Stent Remover Stent Remover Snare ASEPTO Bulb Irrigation Syringe TRACKFINDER Bulb Irrigator SUPREMO - Nitinol Hydrophilic Guidewire Schuller Guidewire Cobra - Nitinol Guidewire HYGUIDE Hydrophilic Guidewire Standard - Straight Tip Guidewire Lunderquist Guidewire King Cobra - Hydrophilic Nitinol Guidewire Standard - J Tip Guidewire Stylet for Pro Embryo Trans, Pro Echo Trans, and Twinkle Embryo Trans Stylet for Bulb Trans Ultra and Bulb Trans Star Echo Trans Embryo Transfer Catheter Embryo Trans Embryo Transfer Catheter Twinkle Embryo Trans Embryo Transfer Catheter Twinkle Pro Embryo Trans Embryo Transfer Catheter with Stylet Pro Echo Trans Embryo Transfer Catheter Soft Obturator for Pro Embryo Trans Soft Obturator for Twinkle Pro Embryo Trans Twinkle Pro Embryo Transfer Catheter Bulb Trans Star Embryo Transfer Catheter Soft Obturator for Pro Echo Trans Stylet for Embryo Trans, Echo Trans, Twinkle Embryo Trans Pro Embryo Trans Embryo Transfer Catheter Bulb Trans Ultra Embryo Transfer Catheter Trial Transfer Catheter for Embryo Trans Pro Embryo Trans Embryo Transfer Catheter with Stylet Twinkle Pro Embryo Trans Embryo Transfer Catheter with Soft Obturator Trial Transfer Catheter for Echo Trans Aspi Hydrophobic Filter Set - ASP-HFS Aspi Suction Bottle with Connector - ASP-SB Aspi Suction Line with Luer Lock Connectors - ASP - SL AspiPump Foot Switch - ASP - FS AspiPump 90D - ASPI-90D Urine Bag Connector Toomey Syringe Ureteral Catheters - all Flex Ureteral Catheters - Krait Auto Core Biopsy Needle SPEEDO Biopsy Needle PRONTO Semi-Auto Biopsy Needle With Coax Needle Ultracore Biopsy Needle - Manual STONE BASKET Intra Uterine Insemination Catheter with Malleable Stylet Intra Uterine Insemination Catheter Intra Uterine Insemination Catheter Shorty Intra Uterine Insemination Catheter Duo Intra Uterine Insemination Catheter Curved Contistrap Male Incontinence Clamp BREAST LOCALIZATION NEEDLE Re-Entry Malecot Catheter Percutaneous Nephrostomy Drainage Set - Malecot Percutaneous Nephrostomy Catheter - Pigtail Percutaneous Nephrostomy Drainage Set - ULTIMA Percutaneous Nephrostomy Drainage Set - Pigtail Percutaneous Nephrostomy Catheter - ULTIMA ULTIMA Direct Puncture Drainage Set Percutaneous Nephrostomy Catheter - Malecot Autocore Biopsy needles Ultracore Biopsy Needles Ureteral Dilator Set Fascial Dilator Set Renal Dilator Renal Dilator With Amplatz Sheath Amplatz Sheath Amplatz Renal Dilator Set NOTTINGHAM One Step Dilator Bite-O-Bite Block Meatal Dilator - Pediatric Meatal Dilator - Adult Chiba Needle - 2 Part Bevel Tip Injection Needle Initial Puncture Needle - 2 Part Trocar Tip Injection Needle Metallic Initial Puncture Needle - 3 Part Bevel Tip MECHLITH - Mechanical Lithotripter

    Establishment Types

    Manufacture Medical Device