BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Nicolay GMBH

    Reg #: 9681377 · FEI: 1000300598 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    121
    Establishment Types
    1
    Classifications
    24

    Registration Details

    Registration Name
    Nicolay GMBH
    Registration Number
    9681377
    FEI Number
    1000300598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GRAF-ZEPPELIN-STRASSE 21
    City
    NAGOLD Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    NICOLAY GMBH
    Operator Number
    9022544
    Address
    GRAF-ZEPPELIN-STRASSE 21, --
    City
    NAGOLD
    State
    Baden-Wurttemberg
    Postal Code
    72202
    Country
    DE

    US Agent

    Business Name
    Registrar corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177 ext. 200

    Products

    Device Name Product Code
    Cable, Electrode IKD
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Computer, Diagnostic, Programmable DQK
    Electrode, Cutaneous GXY
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Oximeter DQA
    Recorder, Paper Chart DSF
    Transducer, Ultrasonic, Obstetric HGL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Continuous Measurement Thermometer FLL
    Blood Pressure Cuff DXQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Monitoring, Perinatal HGM
    System, Network And Communication, Physiological Monitors MSX
    Alarm, Blood-Pressure DSJ
    Transducer, Pressure, Intrauterine HFN
    Transducer, Blood-Pressure, Extravascular DRS
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Computer, Blood-Pressure DSK
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    989803152081 : 5 lead snap IEC colored leadset M1425A : 5-lead Set Telemetrie Grabber, AAMI MS23924 : 3-lead ECG Monolead MS20475 : 4lead MonoLead L- 3420mm IEC2 M1191BL : Reusable Adult SpO2 Sensor M1971A : 5-Lead-Set Grabber IEC, ICU (limb) M1540C : 3 Lead AAMI Trunk Cable 0.9m M1626A_old : 3-Lead-Set Mini-Clip unshld IEC 0.7m 124790.1 : 3-Lead Trunk Cable M1622A : CBL Unshielded 3 Ld Miniclip AAMI 0.45m E9003SY : Grab. Leadset M3527A : 7- lead set snap AAMI (7+3) E9003WL : 3-Lead-Set III 989803171841 : CBL ECG 5 lead Snaps, AAMI + SpO2 406641-007 : Leadwire Shld Snap M1615A : CBL Shld ECG 3-lead Set Snaps, IEC M1968A_old : CBL 5 Leadset Grabber AAMI, ICU M1669A : CBL 3 Lead ECG Trunk AAMI/IEC 2.7m 989803171961 : ECG 6 lead Grabber, IEC, Telemetry M1603A : CBL 3-Lead-Set grabbers, AAMI M1604A : CBL 5 Lead-Set, Snap, Chest, IEC, ICU M1647A : CBL unshl. 5-lead Mini-Clip AAMI 0.7/1.3m M1533A : CBL 4 Lead Set Grabber IEC, ICU Rhythmia HDx IEC ECG IN Cable (Trunk) M1609A : ECG 3-Lead Set Non Shld Mini-Clip 406642-008 : Leadwire Shld Grab M1673A : CBL 3-Leadset, Snap, AAMI, ICU M1671A_old : CBL 3-Leadset, Grabber, AAMI, ICU 406642-010 : Leadwire Shld Grab M1424A : Telemetry 5-Lead-Set, snap AAMI 989803199081 : MX40 Adapter SpO2-only E9003WK : 3-Lead-Set III 989803152061 : 5 lead set grabber IEC colored 989803171851 : CBL ECG 5 lead Grabber, AAMI + SpO2 E9003SP : Leadwire Shld Snap 989803151991 : 3 lead snap AAMI gray leadset M2590A : TELE CBL 3 Lead Set Snap AAMI M1640A : 3 lead ECG Patient Trunk Cable, AAMI 406641-006 : Leadwire Shld Snap 130212 : 5-Lead Set LIMB (AAMI) 7499853 : ECG 6-LEAD TRUST AHA/US, TELEM 989803158251 : Label Kit 5+5 Trunk AAMI / IEC MS14687 : 5lead MonoLead L- 4100mm IEC2 060-0108 : Cable Assembly, 3-Lead E9003RF : 3 Lead ECG LD 2 Cable M1580A : CBL 3-lead ECG Patient Trunk, AAMI 0012-00-1813-02 : Cable, ECG LEAD SET, 5L, IEC 989803152141 : 6 Lead Set grabber IEC colored M1581A : ECG Single Lead Mini-Clip 0.7M 5734400 : ECG 5-LEAD SPACER F.MM 12 M1602A : CBL 5 Lead Snap Chest AAMI, ICU E9003YC : 5-Lead Combiner 989803133841 : ECG 3-lead-set grabber AAMI 989803133921 : ECG 6-lead-set grabber AAMI IAA-00439 : 5-Lead-Set AAMI 130219 : 3-Lead Set (AAMI) MS16157 : ECG 6-LEAD SINGLE-PIN EURO, 1M MS28558 : ECG CBL MONOLEAD 5, AHA/US, 5.3M MS28559 : ECG CBL MONOLEAD 6, EURO, 5.3M M2599A : TELE 5-Lead Combiner/Shield Set M2268A, 989803106091, EEG Trunk Cable 2.7 meter 403064-016 : Leadwire Unshld Clip MS17185 : MONOLEAD 6, EURO, 4.8M 408029-001 : Leadwire Set Lead III Snap 989803199071 : MX40 Adapter 6L+SpO2 989803199091 ECG 5 lead Grabber, IEC, SPU, Tele (ECG Lead Set) 989803171871 ECG 6 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803199071 ECG 5 lead Grabber, AAMI, SPU, Tele (ECG Lead Set) 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803199101 ECG 5 Lead Grabber IEC + SpO2, SPU, Tele 989803171831 ECG 5 lead Grabber, AAMI, Tele (ECG Lead Set) 989803171961 ECG 6 lead Grabber, IEC, Tele (ECG Lead Set) 989803199081 ECG 5 lead Grabber, AAMI + SpO2, SPU, Tele 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171971 ECG 6 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) 989803171931 ECG 5 lead Grabber, IEC, Tele (ECG Lead Set) 989803171861 ECG 6 lead Grabber, AAMI, Tele (ECG Lead Set) 989803171821 ECG 5 lead Snaps, AAMI, Tele (ECG Lead Set) 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele (ECG Lead Set + SpO2 Adapter) M1968A, 989803125841, 5 Leadset, Grabber, AAMI, ICU M1667A, 989803145051, 6 Lead ECG Trunk, AAMI/IEC 2.7m M1973A, 989803125861, 5 Leadset, Grabber, AAMI, OR M1673A, 989803145111, 3 Leadset, Snap, AAMI, ICU M1665A, 989803145041, 6+4 Lead ECG Trunk AAMI/IEC 2.7m M1644A, 989803144991, 5 Leadset, Snap, AAMI, ICU M1669A, 989803145071, 3 Lead ECG Trunk, AAMI/IEC 2.7m M1624A, 989803144941, Unshielded 3 Ld Miniclip AAMI 0.7m M1671A, 989803145091, 3 Leadset, Grabber, AAMI, ICU M1663A , 989803144791, 10 Lead ECG Trunk AAMI/IEC 2m 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC M1949A, 989803125831, 5+5 ECG Trunk Cable AAMI, IEC 2.7m M1675A, M1624A, M1532A, M1968A, M1644A, M1973A, M1976A, M1602A, M1979A, M1680A, Philips M1602A, 989803144911, 5 Lead Snap Chest AAMI, ICU 989803170171, 989803170181, M1667A, M1668A, M1669A, M1949A, M1663A, M1665A, M1671A ,M1673A 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC M1668A, 989803145061, 5 Lead ECG Trunk, AAMI/IEC 2.7m M1675A, 989803145131, 3 Leadset, Grabber, AAMI, OR M1979A, 989803125901, 5 Leadset, Grabber, Chest, AAMI, OR M1976A, 989803125881, 5 Leadset, Grabber,Chest, AAMI,ICU M1680A, 989803145161, 6 Lead Set Grabber, AAMI, ICU M1532A, 989803144841, 4 Lead Set Grabber AAMI, ICU M1191B and M1191BL 989803202391, Telemetry Adapter Masimo SpO2-only (SpO2 Adapter) 989803143411, Remote Event Marker 989803202381, Telemetry Adapter 5-Lead + Masimo SpO2 (ECG + SpO2 Adapter) 989803204291, Telemetry Adapter 6-Lead + Masimo SpO2 (ECG + SpO2 Adapter) 989803202411, ECG 5L Grabber, AAMI, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) 989803202421, ECG 5L Grabber, IEC, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) M1191T 989803172221 Telemetry Adapter 3L+SpO2 (ECG + SpO2 Adapter) 989803172031 ECG Trunk Cable AAMI/IEC (ECG Trunk Cable) 989803172051 Telemetry Adapter 6L+SpO2 (ECG + SpO2 Adapter) 989803172131 Telemetry Adapter SpO2-only (SpO2 Adapter) 989803172151 Telemetry Adapter 5L+SpO2 (ECG + SpO2 Adapter) 989803202421ECG 5L Grabber, IEC, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele (ECG Lead Set + SpO2 Adapter) 989803204291 Telemetry Adapter 6-Lead + Masimo SpO2 (ECG + SpO2 Adapter) 989803202391Telemetry Adapter Masimo SpO2-only (SpO2 Adapter) 989803202381 Telemetry Adapter 5-Lead + Masimo SpO2 (ECG + SpO2 Adapter)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)