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

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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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Manufacturer: Bcm Co., Ltd.× Clear all

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HILZO Esophageal Stent System UDI-DI 08800026643357

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
82 variants
- HILZO Esophageal Stent System EVP1915HC-I
- HILZO Esophageal Stent System EVP2006HC
- HILZO Esophageal Stent System EVP2006HU1-I
- HILZO Esophageal Stent System EVP2008HC
- HILZO Esophageal Stent System EVP2014HC-I
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HILZO Esophageal Covered Stent (PTFE) UDI-DI 08809468540835

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
33 variants
- HILZO Esophageal Covered Stent (PTFE) EVP1809HC2
- HILZO Esophageal Covered Stent (PTFE) EVP1815HC1
- HILZO Esophageal Covered Stent (PTFE) EVP1910HC1
- HILZO Esophageal Covered Stent (PTFE) EVP2011HCS1
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HILZO Esophageal Covered Stent (PTFE/Partially Covered) UDI-DI 08809423568614

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
27 variants
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1809HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1815HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP2009HU1
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HILZO Esophageal Covered Stent (PTFE) with Nylon Suture UDI-DI 08809423567440

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
37 variants
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP1814HC2-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP2011HC1-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP2011HCS2-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP2013HCS2-I
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