BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MEDI.PLAN GMBH & CO. KG

    Reg #: 3033536319 · FEI: 3033536319 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    128
    Establishment Types
    1
    Classifications
    36

    Registration Details

    Registration Name
    MEDI.PLAN GMBH & CO. KG
    Registration Number
    3033536319
    FEI Number
    3033536319
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hofkerstrabe 22
    City
    Dortmund North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K120577

    Owner / Operator

    Firm Name
    MEDI.PLAN GmbH & Co. KG
    Operator Number
    10091549
    Address
    Hofkerstrabe 24
    City
    Dortmund
    State
    DE-NOTA
    Postal Code
    44149
    Country
    DE
    Correspondent
    Amela Karic

    US Agent

    Business Name
    Capote Law Firm
    Contact Name
    Lisa Capote
    Address
    13818 SW 152nd Street, Suite 375
    City
    Miami
    State
    FL
    ZIP
    33177
    Country
    US
    Email
    [email protected]
    Phone
    786 8715680

    Products

    Device Name Product Code
    Mixer, Cement, For Clinical Use JDZ
    Spirometer, Diagnostic BZG
    Stethoscope, Manual LDE
    Set, Administration, Intravascular FPA
    Syringe, Irrigating (Non Dental) KYZ
    System/Device, Pharmacy Compounding NEP
    Filter, Infusion Line FPB
    Dressing, Wound, Occlusive NAD
    Stopcock, I.V. Set FMG
    Retinoscope, Battery-Powered HKM
    Blood Pressure Cuff DXQ
    Elastomer, Silicone, For Scar Management MDA
    Container, I.V. KPE
    Container, Specimen, Sterile FMH
    Syringe, Piston FMF
    Device, Medical Examination, Ac Powered KZF
    Syringe, Antistick MEG
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Bag, Urinary, Ileostomy EXH
    Tape And Bandage, Adhesive KGX
    Speculum, Vaginal, Nonmetal HIB
    Set, Blood Transfusion BRZ
    Otoscope ERA
    Ophthalmoscope, Battery-Powered HLJ
    Ophthalmoscope, Ac-Powered HLI
    Drain, Tee (Water Trap) BYH
    Exophthalmometer HLS
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Dressing, Wound, Drug FRO
    Continuous Measurement Thermometer FLL
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Electrocardiograph DPS
    Protector, Skin Pressure FMP
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    MIXEVAC III, STERILE, CEMENT MIXER PACK 10 703418 Disposable Flow Transducers QTY 25 STETHOSCOPE COMFORT EAR TIPS, BLACK PAIR PACK 1 LUER ACTIVATED VALVE FOR IV ACCESS 0.25ML STERILE NON PYRO CASE 200 BD CATHETER TIP SYRINGE STERILE 50ML PACK 40 FLUID TRANSFER SET PVC VENTED SPIKE CASE 10 EXT SET, STD BORE M/LL 16CM CASE 48 ALLEVYN GENTLE BORDER LITE 15X15CM PACK 10 ALLEVYN GENTLE BORDER 10X10CM PACK 10 ALLEVYN ADH 12.5X12.5CM PACK 10 ALLEVYN NON ADH HEEL 10.5X13.5CM PACK 5 STOPCOCK 4WAY LARGE BORE W/MALE LL CASE 50 RECHARGABLE 3.5V BATTERY, BLACK PACK 1 ONE-LINK STD BORE CATH EXT SET CASE 200 SET EXTENSION ONE-LINK MICROBORE CASE 200 STRAIGHT-TYPE EXTENSION SET, MICROBORE, ONELINK NEEDLE FREE CONNECTOR CASE 200 CONNECTOR IV ONE-LINK NEEDLE-FREE CASE 200 PORT PROTECTOR LUER LOCK DUAL CASE 504 FLEXIPORT BP CUFF REUSABLE 2TB 25-34CM, ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE, SMALL INFANT PACK 1 FLEXIPORT BP CUFF REUSABLE, SMALL ADULT PACK 1 COILED TUBING 8FT, PACK 1 FLEXIPORT BP CUFF REUSABLE 25-34CM, LONG ADULT PACK 1 FLEXIPORT BP CUFF SINGLE USE, ADULT REGULAR PACK 20 FLEXIPORT BP CUFF REUSABLE 1TB 25-34CM, LONG ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE 25-34CM, ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE 1TB, SMALL ADULT PACK 1 FLEXIPORT BP CUFF SINGLE USE, ADULT LONG PACK 20 FLEXIPORT BP CUFF REUSABLE, INFANT PACK 1 FLEXIPORT BP CUFF REUSABLE 2TB, SMALL ADULT PACK 1 MEPIFORM STERIL 4X30CM PACK 5 MEPIFORM 10 X 18 CM PACK 5 MEPIFORM STERIL 5X7.5CM PACK 5 CONTAINER FLUID NON-DEHP 250M CASE 48 BULKTUBE URINALYSIS 8ML 16X100ML W/YLW PACK 100 RAPIDFILL CONNECTORS - RED CASE 50 HALOGEN LAMP 3.5V PACK 6 HALOGEN LAMP BULB 4.6V PACK 6 HALOGEN LAMP BULB 3.5V PACK 6 DIAGNOSTIC LAMP BULB 3.5V PACK 1 HALOGEN LAMP 2.5V PACK 6 BD SAFETYGLIDE SYRINGE 1ML 27GX1/2" TUBERCULIN PACK 100 IRRIGATION SET CYSTO W/LG BORE CLAM CASE 48 Y-TYPE TUR-BLADDER IRRIGATION CASE 12 SET BASIC TPN 10 CASE 48 CLEARLINK PACLITAXEL SET CASE 48 ACTIVELIFE ONE-PIECE DRAINABLE POUCH PACK 10 PRIMAPORE 7.5X5CM PACK 100 OPSITE FLEXIGRID 6X7CM PACK 100 OPSITE 9.5X8.5CM PACK 20 OPSITE 15.5X8.5CM PACK 20 PRIMAPORE 10X8CM PACK 20 OPSITE IV 3000 6X7CM PACK 100 OPSITE 25X10CM PACK 20 PRIMAPORE 20X10CM PACK 20 OPSITE FLEXIGRID 15X20CM PACK 10 OPSITE 6.5X5CM PACK 100 OPSITE FLEXIFIX 10CMX10M PACK 1 IV 3000 OPSITE 10CM X 12CM PACK 50 PRIMAPORE 15X8CM PACK 20 OPSITE FLEXIFIX 5CMX10M PACK 1 DURASHOCK DS58 FAMILY KIT PACK 1 DURASHOCK ONE PIECE BLOOD PRESSURE CUFF ADULT PACK 1 ANEROID WALL MOUNT W/ADULT CUFF, PACK 1 ADULT ANEROID ONE PIECE WITH CUFF PACK 1 FLEXIPORT BP CUFF REUSABLE, ADULT PACK 1 FLEXIPORT BP CUFF ONE PIECE, CHILD PACK 1 KLEENSPEC EAR SPECULUM DISPENSER W/STORAGE, PACK 10 FILTER BLOOD CASE 48 OTOSCOPE HEAD LED MACROVIEW, PACK 1 OTOSCOPE MACROVIEW 3.5V HALOGEN BULB, PACK 1 OTOSCOPE REUSABLE EAR SPECULUM 5MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 3MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 4MM, PACK 1 EAR TIPS FOR 29350, PACK 25 OTOSCOPE REUSABLE EAR SPECULUM 3MM, PACK 1 OTOSCOPE WALL TRANSFORMER HANDLE, PACK 1 OTOSCOPE SPECULA DISPENSER PACK 10 OTOSCOPE JUNIOR SET W/HANDLE AND CASE PACK 1 OTOSCOPE INSUFFLATION BULB PACK 1 OTOSCOPE MACROVIEW 3.5V PACK 1 RECHARGABLE HANDLE PLUG IN PACK 1 JUNIOR POCKETSCOPE SET PACK 1 EAR SPECULUM SET, PACK 4 OTOSCOPE REUSABLE EAR SPECULUM 4MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 5MM, PACK 1 BD SYRINGE 1ML LUER-LOCK PACK 100 BD ECLIPSE SYRINGE 3ML 23GX1 PACK 50 BD ECLIPSE SYRINGE 3ML 25GX5/8" PACK 50 OPHTHALMOSCOPE 3.5V CONTINU-FLO SOLUTION SET, M/LL, NON-VNTD SPIKE, CLEARLINK CASE 48 CONTINU-FLO DROP SET 60 DROP 8 CM CASE 48 WATER TRAP, WATERLOCK 2 PACK 12 DIAGNOSTIC WALL SYSTEM (GREEN) PACK 1 SOLUTION SET, M/LL, 2 INTERLINK INJ SITES CASE 48 BD VACUTAINER LUER-LOK ACCESS DEVICE PACK 198 ACTICOAT FLEX 3 10X10CM PACK 12 SURETEMP WALL MOUNT HOLDER PACK 1 SURETEMP PLUS 690 THERMOMETER W/9' PROBE PACK 1 OPHTHALMOSCOPE 3.5V PACK 1 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 18GX1.25" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 20GX1" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 22GX1" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 24GX3/4" PACK 20 CONTINU-FLO SOLUTION SET, M/LL, 0.20 MICRON FILTER, 2 INTERLINK INJ SITES CASE 48 SET CO FLO INJ 10 DROP 102 CASE 48 STRAIGHT-TYPE EXTENSION SET, M/LL, STD BORE, 0.20 MICRON FILTER CASE 48 INTRASITE GEL 15G PACK 10 JELONET STER 10X10CM PACK 10 SET IV EXTENSION 2-SITE CLEARLINK CASE 48 ALLEVYN LIFE 15.4X15.4CM PACK 10 ALLEVYN LIFE SACRUM 21.6X23CM PACK 10 ALLEVYN GENTLE BORDER 7.5X7.5CM PACK 10 ALLEVYN GENTLE BORDER 12.5X12.5CM PACK 10 ALLEVYN GENTLE BORDER 17.5X17.5CM PACK 10 ALLEVYN GENTLE BORDER LITE 5X5CM PACK 10 ALLEVYN GENTLE BORDER LITE 7.5X7.5CM PACK 10 ALLEVYN LIFE 21X21CM PACK 10 ALLEVYN LIFE SACRUM 17.2X17.5CM PACK 10 BD SAFETYGLIDE NEEDLE 23GX1" PACK 50 BD SAFETYGLIDE NEEDLE 25GX5/8" PACK 50 BD SAFETYGLIDE NEEDLE 25GX1-1/2 PACK 50 BD SAFETYGLIDE NEEDLE 25GX1" PACK 50 BD SAFETYGLIDE NEEDLE 18GX1-1/2 PACK 50 BD SAFETYGLIDE NEEDLE 21GX1" PACK 50 EXT SET, STD BORE N/DEHP M/LL STR 0.5ML 14CM CASE 200 SET EXTENSION ONE-LINK NON-DEHP Y-T CASE 200 SYSTEM CLEARLINK NON-DEHP DISPOSABLE CASE 48

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device