Identity
- Trade Name
- exofin HVTSA, 1g EUDAMED
- Device Name
- exofin EUDAMED
- Model / Reference
- exofin EUDAMEDEXC92010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854137001856 EUDAMED
- Basic UDI-DI
- 854137001MPNKL 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 HVTSA, 1g 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 | 854137001MPNKL | 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 5c9aa721-a100-4012-814c-e4662281afa8 61 fields · synced Sep 18, 2026