- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Apr 2, 2026
B-08800038112285EGIS Biliary Double Bare Stent is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by VASNOVA INC.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800038112285BDB080818XKR-MF-000015781G1 097436 0011No 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.(01)08800038112285
2 warnings recorded — scroll inside the panel to see all entries.
Contraindications for the EGIS Biliary Stents include, but may not be limited to: Patients with angina or coagulopathy or uncorrected bleeding disorders, Strictures that do not allow passage of a guidewire, Patients with large-volume ascites, Extensive hepatic metastases precluding a percutaneous transhepatic approach, Neonatal, pediatric and adolescent use, Benign strictures – except for removable configurations, Any use other than those specifically outlined under indications for use, Patients with contraindicated endoscopic procedure
The patients who have implanted this device may be scanned safely on a MRI Environment that satisfies as below: • Static magnetic Field of 1.5-Tesla and 3.0-Tesla • Maximum spatial gradient magnetic field of 3,000 gauss/cm • Maximum MR system reported, whole body averaged specific absorption rate(SAR) of 2 w/kg Additional description . Under the above defined scanning conditions, the maximum temperature rise is expected to be less than 2.8℃ when the EGIS Biliary stent was MRI performed for 15 minutes of scanning. From the non-clinical testing, the distorted image due to the medical device was extended up to 2.5 mm when it was scanned under T1 SE, GRE pulse sequence of 3.0-Tesla MRI.
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 Czechia; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Sweden | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
P0502BILIARY AND PANCREATIC PROSTHESESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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 →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 →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.
View in glossary →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 →No certificate specifically references this device's Basic UDI-DI.
B-08809220604737On the marketEGIS Biliary Double Bare StentB-08809220605017On the marketEGIS Biliary Double Bare StentB-08809220604904On the marketEGIS Biliary Double Bare StentB-08800038112377On the marketEGIS Biliary Double Bare StentB-08809220604959On the marketEGIS Biliary Double Bare StentB-08800038112322On the market