BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN ROGIN MEDICAL CO., LTD

    Reg #: 3015136927 · FEI: 3015136927 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    121
    Establishment Types
    3
    Classifications
    51

    Registration Details

    Registration Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Registration Number
    3015136927
    FEI Number
    3015136927
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242383

    Owner / Operator

    Firm Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Operator Number
    10058732
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518129
    Country
    CN
    Correspondent
    Xiaoran Xu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Dermatome GFD
    Cup, Prophylaxis EHK
    Accessories, Implant, Dental, Endosseous NDP
    Locator, Root Apex LQY
    Tray, Impression, Preformed EHY
    Instrument, Contouring, Matrix, Operative EKF
    Handle, Instrument, Dental EJB
    Syringe, Irrigating (Dental) EIB
    Loupe, Diagnostic/Surgical FSP
    Band, Elastic, Orthodontic ECI
    Accessories, Retractor, Dental EIF
    Unit, Suction Operatory EBR
    Instrument, Diamond, Dental DZP
    Forceps, Dressing, Dental EFL
    Burnisher, Operative EKJ
    Gutta-Percha EKM
    Wax, Dental, Intraoral EGD
    Light, Operating, Dental EAZ
    Drill, Dental, Intraoral DZA
    Microscope, Surgical EPT
    Bur, Dental EJL
    Gauge, Depth, Instrument, Dental EIL
    Needle, Dental DZM
    Evacuator, Oral Cavity EHZ
    Point, Paper, Endodontic EKN
    File, Pulp Canal, Endodontic EKS
    Band, Preformed, Orthodontic ECM
    Holder, Film, X-Ray EGZ
    Post, Root Canal ELR
    Syringe, Restorative And Impression Material EID
    Instrument, Ligature Tucking, Orthodontic ECP
    Strip, Polishing Agent EHM
    Handpiece, Direct Drive, Ac-Powered EKX
    Plier, Orthodontic JEX
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Tube, Orthodontic DZD
    Unit, Operative Dental, Accessories NRD
    Dam, Rubber EIE
    Bone Particle Collector MXP
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Instrument, Filling, Plastic, Dental EIY
    Spring, Orthodontic ECO
    Wire, Orthodontic DZC
    Disinfector, Medical Devices MEC
    Instruments, Dental Hand DZN
    Broach, Endodontic EKW
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Epilator, High Frequency, Tweezer-Type KCX
    Bracket, Metal, Orthodontic EJF
    Mirror, Mouth EAX
    Articulators EJP

    Proprietary Names

    cutting machine PROPHY ANGLES saw blade/Pindex/crucible, Dental Implant Instruments, Implant Locator, implant Wrench, Implant stability tester Apex Locator Impression trays/trays Sectional Contoured Metal Matrices, Rectangular Matrix Bands,Coat matrix bands, Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix Strips Reel Matrix System, Reel Matrices, Saddle Contoured Metal Matrices Universal Kit for Premolars, Obturation pen, Obturation Pen, Obturation Gun Infinity Endo Obturation Gun Infinity Endo Obturation Pen Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit dental magnifier Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges Dental Extraoral Suction unit Infinity Endo File Removal Kit DIAMOND BURS tweezers E-LITE Polisher Gutta Percha Cutter, Gutta Percha Obturator Orthodontic Wax LED Curing light Infinity Endo Curing Light Peeso Reamers Drills for dental post Drills for fibre post Gate Drills Dental Microscope Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond Polisher Infinity Endo Diamond Burs Endo Block, Endo Ruler, Endo Gauge, Resin Block (dental)needle, Root Canal Irrigation Needle Vacuum Former Absorbent Paper Points Infinity Endo Blue Files Microscope Reamers, Microscope C+ Files, NiTi Hand Use Files, NiTi K Files/H Files/Reamers, Stainless Steel K Files/H Files/Reamers Files holder, C+ Files, U Files, Microscope Files NiTi Rotary Files (Entrance File; Vari-Taper File; Retreatment Files; SUP-Taper File; Blue HA Sup-Taper Files; Super Flexi Files); EZ SHAPER, EZ, R-Shaper, Ino-shaper Files, C Pro Files, PF Files, Micro-Prober, Micro-Shaper, Infinity Endo Retreatment Files Infinity Endo Hedstrom Files Gold HA Sup-Taper files; Wave File; Recip-one file; Multi-taper files; Sup-Taper Next; Pre-shaper Files; Hero-S Files; VET REAMERS, Super Flexi Files Gold, Super Flexi Files Blue, TRI-SHAPE FILES, T-TAPER FILES, UC FILES, Wave File, Wave File Gold HA, Wave File Blue HA, PRIMARY Files, Infinity Endo Ultra Conservative Files R-SHAPER Files, R-SHAPER Files blue, Recip-One Files, U Files, Hero-S Files, Multi Taper Files, Entrance Files, Vari-Taper Files, R-SHAPER Files(aurora version), Ino-Shaper Files (aurora version), Sup-taper files (aurora version), Super Flexi Files (aurora version), Stainless Steel C+ Files, Stainless Steel C PRO Files, Stainless Steel Flexi Files, Microsope K-Files, Microscope H-Files, Micro-opener, Square Broaches, K-Flexi Files, DK-Files, Fire-Files, Pro-path Files, Sup-path Files, Sup-Taper Files Next BLUE, Sup-Taper Files Next Gold, Endo Training Kit, Niti Spreader, Niti Plugger PD FILES, VET K Files, VET H Files, VET REAMERS, Sup-Taper Files Gold HA, Sup-Taper Files Blue HA, Sup-Taper Files HA, T-PATH FILES, R-PROC FILES, SUP-PATH FILES, Hand Use Super Files, Nickel Titanium K-Files, SUP-PATH PRO, 3D-Flexi Shaper files, TS ELITE-Glider, TS ELITE Files, Apical shapers, Patency Finder, PF Files, Nickel Titanium H-Files, Nickel Titanium Reamers, Vet Endo Rotary Files, Access Files, Shapping Reamers, Retreatment Files, Infinity Endo C Files Ino-Shaper Files Blue, Ino-Shaper Files Gold, Infinity Endo Stainless Steel K files Micro-Prober, Micro-Shaper, Endo Training Kit Infinity Endo Gold Files Infinity Endo Coronal Shaper Gold Files Nickel Titanium C+ Files, Nickel Titanium C PRO Files, Revone Files, Acer Files, Sone Files, GC Files, Recip-One Files BLUE, Recip-One Files Gold, Sup-Taper Files Next, Nickel Titanium Flexi Files , VET K Files, VET H Files, EZ Shaper, EZ Shaper PRO, UNI-SHAPE Files, SF-SHAPE FILES, Infinity Endo Coronal Shaper Blue Files Stainless Steel K-Files, Stainless Steel H-Files, Stainless Steel Reamers, Molar Bands Dental X-Ray holder Fibre Post, Dental Screw Post, Orthodontic Microimplant Mixing Tips Ligature Gun Polishing Disc/Polishing Strips/Polishing Cup/Polishing Brushes Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) Orthodontic Pliers Dental Lab Materials – Brass Dowel pins Buccal Tubes/ compressors Dental Dam Clamp Tray, Dental Dam Punching Template, Rubber Dam, Rubber dam accessories (Rubber Dam Clamp), Rubber Dam Instrument Kit Dental Dam Frame, Dental Dam Heavy, Dental Dam Sterilization container Dental Dam Clamp, Dental Dam Punch, Dental Forceps, Dental Dam System, dental dam instrument kit, Dust Collector Niti Spreader, Niti Plugger Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers Paste Carriers Gutta-Percha Obturation System (ELITE FILL-E); Microscope Paste Carriers Microscope paste carriers super floss Microscope paste carriers additional parts Springs Arch Wire/Straight Wires Root Canal Files disinfection box Root Canal Irrigation Needle; Matrix Strips Endo Motor, matrices, Endo Extractor Barbed Broaches, Barbed Broaches Square Broaches Micro Applicator Vibrator Orthodontic Metal Brackets/ Metal V-slot Brackets/ Self-Ligating Brackets/ Ceramic Bracket/ Photographic Mirrors/mouth mirror, Defogging mouth mirror Oral Mirror articulators/flask

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device