Identity
- Trade Name
- EXPASYL x6 EUDAMED
- Device Name
- EXPASYL EUDAMED
- Model / Reference
- 294010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760243007033 EUDAMED
- Basic UDI-DI
- 376024300expasyl27 EUDAMED
- Unit of Use DI
- 03760243009808 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Category: Gingival retraction cord, non-medicated
EXPASYL x6 by Acteon Manufacturing — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gingival retraction cord, non-medicated.
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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 | 376024300expasyl27 | Class I | Active |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (1)
- EUDAMED c5c0f90d-6180-4af5-b977-d51fa76a96b4 61 fields · synced May 29, 2026