Identity
- Device Name
- exofin Fusion Skin Closure System 22cm EUDAMED
- Model / Reference
- EF70422CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854137001399 EUDAMED
- Basic UDI-DI
- 854137001OMDJZ EUDAMED
- Direct Marketing DI
- 00854137001399 EUDAMED
- EMDN Code
- H900199 TISSUE ADHESIVES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
exofin Fusion Skin Closure System 22cm by Chemence Medical Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 854137001OMDJZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chemence Medical Inc.
- EUDAMED SRN
- US-MF-000000888
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (1)
- EUDAMED 35dfecc4-ac18-423c-bd91-451601359ef4 61 fields · synced Sep 18, 2026