Identity
- Trade Name
- EXPASYL Exact x5 EUDAMED
- Device Name
- EXPASYL EUDAMED
- Model / Reference
- 299235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760243007194 EUDAMED
- Basic UDI-DI
- 376024300expasyl27 EUDAMED
- Unit of Use DI
- 03760243001048 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
EXPASYL Exact x5 by Acteon Manufacturing — Class I — 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 | 376024300expasyl27 | Class I | Active |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (1)
- EUDAMED c9742bff-1345-4385-9907-f6289e4f4001 61 fields · synced Jun 18, 2026