Identity
- Device Name
- WoundClot EUDAMED
- Model / Reference
- 102055101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016339024 EUDAMED
- Basic UDI-DI
- B-07290016339024 EUDAMED
- EMDN Code
- M040404 CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
WoundClot by Core Scientific Creations Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K160679 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07290016339024 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Core Scientific Creations Ltd
- EUDAMED SRN
- IL-MF-000008531
- FDA Applicant
- Core Scientific Creation , Ltd.
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (2)
- EUDAMED 8eba154c-95ee-413a-ba84-b22afb14221e 85 fields · synced Jun 18, 2026
- FDA 510(k) K160679 1 fields · synced May 18, 2026