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    DICOM VISION S.R.L. STARTUP COSTITUITA A NORMA DELL'ART.4 COMMA 10 BIS DEL DECRETO LEGGE 24 GENNAIO 2015, N.3

    Manufacturer
    🇮🇹 Italy

    THD Face Mask F4 20 N M S - A

    Device
    EU MDR · Eu Md Class 1 ·THD S.P.A.·On the market

    THD Face Mask F4 50 N M R - A

    Device
    EU MDR · Eu Md Class 1 ·THD S.P.A.·On the market

    Electrode Na

    Device
    EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

    NA CONDITIONING SOLUTION

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    Papier na vyšetrovací stôl

    Device
    EU MDR · Eu Md Class 1 ·ERREBI PAPER SRL INDUSTRIA CARTARIA·On the market

    DNA/RNA-Prep NA

    Device
    EU IVDR · Eu Ivd Class A ·Sacace Biotechnologies S.r.l·On the market·32 countries

    NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Electrode Na

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·1 device

    NA CONDITIONING SOLUTION

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·2 devices

    DNA/RNA-Prep NA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sacace Biotechnologies S.r.l·19 devices

    Podkłady z celulozy perforowane, na rolce 263 odcinki, perforacja co 38 cm

    Device
    EU MDR · Eu Md Class 1 ·ERREBI PAPER SRL INDUSTRIA CARTARIA·On the market

    Podkłady z celulozy perforowane, na rolce 132 odcinki, perforacja co 38 cm

    Device
    EU MDR · Eu Md Class 1 ·ERREBI PAPER SRL INDUSTRIA CARTARIA·On the market

    Podkłady z celulozy perforowane, na rolce 132 odcinki, perforacja co 38 cm

    Device
    EU MDR · Eu Md Class 1 ·ERREBI PAPER SRL INDUSTRIA CARTARIA·On the market

    COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only

    FDA Enforcement
    Class II ·Terminated·Copan Italia·September 15, 2021

    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    MyLab Seven, Model 6400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Gamma, Model 7410

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Alpha, Model 7400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    3A HEALTH CARE S.r.l.

    Manufacturer
    🇮🇹 Italy·10 Basic UDI-DIs·61 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.