Identity
- Trade Name
- derma+flex QS CE, 0.7g EUDAMED
- Device Name
- exofin EUDAMED
- Model / Reference
- exofin EUDAMEDQS70810CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854137001436 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
derma+flex QS CE, 0.7g 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 8a46d90b-5439-48ba-a168-6913989b4202 61 fields · synced Sep 18, 2026