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Registry EUDAMED ~115 FDA 510(k) FDA PMA GUDID ~285

Country / market United States ~285

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Türkiye ~115

Risk class Class I Class IIa Class IIb ~115 Class III Class II (US) ~285

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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HILZO Esophageal Covered Stent (PTFE/Partially Covered) UDI-DI 08809423568652

Bcm Co., Ltd.,South Korea

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb
27 variants
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1812HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1813HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1908HU1
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1908HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1912HU1
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1912HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1914HU1
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HILZO Esophageal Stent System UDI-DI 08800026646648

Bcm Co., Ltd.,South Korea

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb
82 variants
- HILZO Esophageal Stent System EVP1808HU-I
- HILZO Esophageal Stent System EVP1809HU-I
- HILZO Esophageal Stent System EVP1814HU
- HILZO Esophageal Stent System EVP1909HU
- HILZO Esophageal Stent System EVP1910HC-I
- HILZO Esophageal Stent System EVP1910HU-I
- HILZO Esophageal Stent System EVP2006HU2-I
- HILZO Esophageal Stent System EVP2011HUS2
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HILZO Esophageal Covered Stent (PTFE) with Nylon Suture UDI-DI 08809423566399

Bcm Co., Ltd.,South Korea

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb
37 variants
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HILZO Esophageal Covered Stent (PTFE) UDI-DI 08809468540941

Bcm Co., Ltd.,South Korea

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb
33 variants
- HILZO Esophageal Covered Stent (PTFE) EVP2009HCS2
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