EUDAMED last updated this device on Aug 10, 2026

HILZO Biliary Uncovered Stent

B-08809423560441

On the marketClass IIb

Applicable legislation: —
Organization name: BCM Co., Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08809423560441
Reference / catalog number: BV0910

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

HILZO Biliary Uncovered Stent is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by BCM Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: HILZO Biliary Uncovered Stent
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08809423560441
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08809423560441
Reference / catalog number: BV0910
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08809423560441

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P0502BILIARY AND PANCREATIC PROSTHESES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Türkiye; available across 19 countries total.

Country	On market since	Until
TürkiyePrimary placement	Oct 19, 2015	Still on market
Austria	Apr 3, 2019	Still on market
Belgium	Oct 18, 2019	Still on market
Cyprus	Jun 20, 2023	Still on market
Czechia	Jan 15, 2019	Still on market
Germany	Dec 1, 2016	Still on market
Denmark	Nov 27, 2015	Still on market
Estonia	Aug 24, 2018	Still on market
EL	Mar 19, 2018	Still on market
Spain	Jan 14, 2019	Still on market
France	Feb 16, 2017	Still on market
Croatia	Apr 25, 2024	Still on market
Hungary	Feb 25, 2025	Still on market
Ireland	Mar 11, 2019	Still on market
Italy	May 22, 2017	Still on market
Netherlands	May 2, 2016	Still on market
Norway	Mar 21, 2023	Still on market
Poland	Jan 13, 2026	Still on market
Sweden	Jul 10, 2024	Still on market

Related searches

Class IIb medical devices in EUDAMED

Device identification

Trade name: HILZO Biliary Uncovered Stent
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08809423560441
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08809423560441
Reference / catalog number: BV0910
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Türkiye; available across 19 countries total.

Country	On market since	Until
TürkiyePrimary placement	Oct 19, 2015	Still on market
Austria	Apr 3, 2019	Still on market
Belgium	Oct 18, 2019	Still on market
Cyprus	Jun 20, 2023	Still on market
Czechia	Jan 15, 2019	Still on market
Germany	Dec 1, 2016	Still on market
Denmark	Nov 27, 2015	Still on market
Estonia	Aug 24, 2018	Still on market
EL	Mar 19, 2018	Still on market
Spain	Jan 14, 2019	Still on market
France	Feb 16, 2017	Still on market
Croatia	Apr 25, 2024	Still on market
Hungary	Feb 25, 2025	Still on market
Ireland	Mar 11, 2019	Still on market
Italy	May 22, 2017	Still on market
Netherlands	May 2, 2016	Still on market
Norway	Mar 21, 2023	Still on market
Poland	Jan 13, 2026	Still on market
Sweden	Jul 10, 2024	Still on market

HILZO Biliary Uncovered Stent

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

Legacy certificates

Related devices