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Registry EUDAMED ~115 FDA 510(k) FDA PMA GUDID ~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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Manufacturer: Bcm Co., Ltd.× Clear all

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HILZO Esophageal Covered Stent (PTFE) UDI-DI 08809468542075

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
33 variants
- HILZO Esophageal Covered Stent (PTFE) EVP1813HC1
- HILZO Esophageal Covered Stent (PTFE) EVP2014HC1
- HILZO Esophageal Covered Stent (PTFE) EVP2015HCS1
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HILZO Esophageal Stent System UDI-DI 08800026640264

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
82 variants
- HILZO Esophageal Stent System EVP1812HC
- HILZO Esophageal Stent System EVP1815HC-I
- HILZO Esophageal Stent System EVP2006HCS
- HILZO Esophageal Stent System EVP2009HCS
- HILZO Esophageal Stent System EVP2011HU-I
- HILZO Esophageal Stent System EVP2014HC
- HILZO Esophageal Stent System EVP2014HU
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HILZO Esophageal Covered Stent (PTFE) with Nylon Suture UDI-DI 08809423567532

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
37 variants
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP1807HC1-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP1907HC2-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP2008HC2-I
- HILZO Esophageal Covered Stent (PTFE) with Nylon Suture EVP2008HCS2-I
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HILZO Esophageal Covered Stent (PTFE/Partially Covered) UDI-DI 08809423569833

Bcm Co., Ltd.,South Korea Class IIb

Active CE MDD EUDAMEDGUDID IIb
27 variants
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1808HU2
- HILZO Esophageal Covered Stent (PTFE/Partially Covered) EVP1811HU2
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