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EUDAMED last updated this device on May 24, 2026
B-08800038102804EGIS Esophageal e-PTFE Covered 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 Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800038102804EEC201707(01)08800038102804
European Medical Device Nomenclature — the EU product classification assigned to this device.
P050199ESOPHAGEAL PROSTHESES - OTHER2 warnings recorded — scroll inside the panel to see all entries.
Contraindications for the EGIS Esophageal Stent include, but may not be limited to: • Serious blood clotting disorders • Placement in necrotic chronically bleeding tumors • Placement in polypoid lesions • Extremely narrow and rigid strictures that cannot be dilated to allow passage of the introducer system, guidewire • Patients, with whom endoscopic techniques cannot be performed and/or are contraindicated • Cannot be suited for neonatal, pediatric and adolescent use. • If there is an abscess/perforation in the abdominal cavity • Use other than those specifically presented for intended purposes • Patients with hemorrhagic disease • Suspected perforation or symptoms of perforation are about to appear.
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 3.1℃ when the EGIS Esophageal 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 4.0 mm when it was scanned under T1 SE, GRE pulse sequence of 3.0-Tesla MRI
KR-MF-000015781No 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.G1 097436 0011Primary placement in Belgium; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
| EL | — | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 →B-08800038103900On the marketEGIS Esophageal e-PTFE Covered Partial StentB-08800038103849On the marketEGIS Esophageal e-PTFE Covered Partial StentB-08800038103832On the marketEGIS Esophageal e-PTFE Covered StentB-08800038102750On the marketEGIS Esophageal e-PTFE Covered StentB-08800038102699On the marketEGIS Esophageal e-PTFE Covered StentB-08800038102682On the marketNo certificate specifically references this device's Basic UDI-DI.