Identity
- Trade Name
- HILZO Esophageal stents FDA UDI
- Generic Name
- Polymer-metal oesophageal stent FDA UDI
- Model / Reference
- EVP2010HCS2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809423560144 FDA UDI
- FDA Product Code
- ESW FDA UDI
- GMDN Term
- Polymer-metal oesophageal stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3610 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Polymer-metal oesophageal stent
HILZO Esophageal stents by BCM Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymer-metal oesophageal stent.
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- HANAROSTENT® Esophagus TTS(NCN) — M.I.Tech Co., Ltd. · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- Esophageal TTS Stent — Taewoong Medical · Class II
- HANAROSTENT® Esophagus TTS(CCC) — M.I.Tech Co., Ltd. · Class II
- HANAROSTENT® Esophagus (NCN) — M.I.Tech Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- BCM Co., Ltd.
Sources (1)
- FDA UDI ceb920c9-e4d4-49a6-9743-ee76f6b32681 32 fields · synced May 30, 2026