Identity
- Trade Name
- Eleview FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g. polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. it is typically a gel-like substance containing an emulsion of fats and salts, and may include a dye. This is a single-use device. FDA UDI
- Model / Reference
- CB-17-04 FDA UDI
- Description
- A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g. polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. it is typically a gel-like substance containing an emulsion of fats and salts, and may include a dye. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391530190015 FDA UDI
- FDA Product Code
- PLL FDA UDI
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Submucosal lift solution
Eleview by Cosmo Technologies, Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal lift solution.
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ORISE™ Gel — Boston Scientific · Class II
- EndoClot SIS — EndoClot Plus, Inc. · Class II
- ORISE™ Gel — Boston Scientific · Class II
- ASCENDO submucosal lifting agent — US Endoscopy · Class II
- Ascendo — US Endoscopy · Class II
- Blue Eye — THE STANDARD CO., LTD. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cosmo Technologies, Ltd.
Sources (2)
- FDA UDI deac0eae-2137-4a79-bdca-29afa8131511 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026