Identity
- Trade Name
- EndoClot® EUDAMEDEndoClot FDA UDI
- Generic Name
- Submucosal lift solution FDA UDI
- Device Name
- EndoClot® Submucosal Injection System EUDAMED
- Model / Reference
- SIS-15 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972011720226 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16972011720226 EUDAMED
- FDA Product Code
- PLL FDA UDI
- EMDN Code
- M04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
- GMDN Term
- Submucosal lift solution FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
EndoClot® by EndoClot Plus Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16972011720226 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- EndoClot Plus Co., Ltd.
- EUDAMED SRN
- CN-MF-000003672
- Authorised Representative
- ClotPlus Limited IE-AR-000002109
Sources (2)
- EUDAMED 4a9bbbc2-bfc4-4d95-8efa-4b7e08b26044 61 fields · synced Jul 27, 2026
- FDA UDI 5f5b1f06-af5a-4cd5-a147-f94a52594691 33 fields · synced May 30, 2026