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EndoClot®
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ECA2302Ref EA230Ref SIS-15Ref SS-10Ref Section 14 Declaration of ConformityRef SIS-30Ref ECA2303
Identity
- Trade Name
- EndoClot® EUDAMED
- Device Name
- EndoClot® Adhesive EUDAMEDEndoClot® Submucosal Injection System EUDAMED
- Model / Reference
- ECA2302 EUDAMEDEA230 EUDAMEDSIS-15 EUDAMEDSS-10 EUDAMEDSection 14 Declaration of Conformity EUDAMEDSIS-30 EUDAMEDECA2303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 46972011720135 EUDAMED56972011720132 EUDAMED16972011720127 EUDAMED26972011720223 EUDAMED56972011720125 EUDAMED36972011720237 EUDAMED26972011720230 EUDAMED36972011720213 EUDAMED16972011720233 EUDAMED36972011720138 EUDAMED16972011720141 EUDAMED26972011720131 EUDAMED46972011720128 EUDAMED
- Basic UDI-DI
- B-46972011720135 EUDAMEDB-56972011720132 EUDAMEDB-16972011720127 EUDAMEDB-26972011720223 EUDAMEDB-56972011720125 EUDAMEDB-36972011720237 EUDAMEDB-26972011720230 EUDAMEDB-36972011720213 EUDAMEDB-16972011720233 EUDAMEDB-36972011720138 EUDAMEDB-16972011720141 EUDAMEDB-26972011720131 EUDAMEDB-46972011720128 EUDAMED
- EMDN Code
- M040504 INORGANIC HAEMOSTATIC DEVICES EUDAMEDM04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
EndoClot® by EndoClot Plus Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190677 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191254 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K162197 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-46972011720135 | Class IIa | Active |
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Manufacturer
- Manufacturer
- EndoClot Plus Co., Ltd.
- EUDAMED SRN
- CN-MF-000003672
- Authorised Representative
- ClotPlus Limited IE-AR-000002109
Sources (14)
- EUDAMED 90fb1380-dc3e-487e-bca6-247258da8a61 61 fields · synced Aug 3, 2026
- EUDAMED f9d80fcf-12a1-41c6-a184-2a38628d0d0a 61 fields · synced May 17, 2026
- EUDAMED 92ddf379-da62-4173-810f-f3e6fe9fa18f 61 fields · synced May 17, 2026
- EUDAMED 8be9b6b0-3e3f-4f4e-b4c1-e059b96fb289 61 fields · synced May 17, 2026
- EUDAMED 97dac944-e7f5-4127-b0b8-6fe5ec0ff9c2 61 fields · synced May 17, 2026
- EUDAMED 58aa8a34-22fd-46b5-8e10-16f309f80fa1 61 fields · synced May 17, 2026
- EUDAMED 54cdbea7-5cca-4cfd-9b17-087f4c38d8d5 61 fields · synced May 18, 2026
- EUDAMED 3c71efe3-ce37-4e84-82d5-2d101eed9d9f 61 fields · synced May 18, 2026
- EUDAMED 0d3c4791-f625-4119-8ac5-a86c637b5da3 61 fields · synced May 19, 2026
- EUDAMED 500cacd7-c5ee-46e7-9689-63b4fd307957 61 fields · synced May 19, 2026
- EUDAMED 6dbd9f60-fbae-4ccd-b372-1ef811099a2e 61 fields · synced May 19, 2026
- EUDAMED 4d051037-3d7b-40d7-bf43-3b07082c56ac 61 fields · synced May 19, 2026
- EUDAMED 1e8e940d-0de2-4a7b-9e19-11ceab32275b 61 fields · synced May 19, 2026
- FDA 510(k) K190677 1 fields · synced May 18, 2026