Identity
- Trade Name
- EndoClot® EUDAMED
- Device Name
- EndoClot® Polysaccharide Hemostatic System EUDAMED
- Model / Reference
- EPK2302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10856886003041 EUDAMED
- Basic UDI-DI
- B-10856886003041 EUDAMED
- EMDN Code
- M040501 POLYSACCHARIDE HAEMOSTATIC DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10856886003041 | Class III | Active |
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Manufacturer
- Manufacturer
- EndoClot Plus, Inc.
- EUDAMED SRN
- US-MF-000003502
- Authorised Representative
- ClotPlus Limited IE-AR-000002109
Sources (1)
- EUDAMED b19b4adf-8584-4684-9ebe-d4f1d9c8f0ef 61 fields · synced May 22, 2026