- Organization name
- UDI-DI code
- Reference / catalog number
KR-MF-0000172922195-MED-2012801HILZO Esophageal Stent System is an MDD-legacy 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.
EUDAMED last updated this device on Aug 10, 2026
B-08800026612889Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08800026612889
1 warning recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08800026612889Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08800026612889EVP2013FC2UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
P050101GASTRO-ESOPHAGEAL REFLUX CORRECTION PROSTHESESB-08800026645870On the marketHILZO Esophageal Stent SystemB-08800026640257On the marketHILZO Esophageal Stent SystemB-08800026640554On the marketHILZO Esophageal Stent SystemB-08800026646686On the marketHILZO Esophageal Stent SystemB-08800026642541On the marketHILZO Esophageal Stent SystemB-08800026631323On the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.