Identity
- Trade Name
- EXPASYL EUDAMEDFDA UDI
- Generic Name
- Gingival retraction kit FDA UDI
- Device Name
- EXPASYL EUDAMED6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas. FDA UDI
- Model / Reference
- 294100 EUDAMEDEXPASYL FDA UDI
- Description
- 6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas. FDA UDI
Identifiers
- Catalog Number
- 294100 FDA UDI
- Primary DI / UDI-DI
- 03760243000775 EUDAMEDFDA UDI
- Basic UDI-DI
- 376024300expasyl27 EUDAMED
- 510(k) Number
- K050180 FDA UDI
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Expasyl by Acteon Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376024300expasyl27 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED fc4b4dff-d69d-4898-b63a-64fec91c260a 61 fields · synced Jul 22, 2026
- FDA UDI 47c7d23d-c18d-44c1-bb24-09ecdc62e671 37 fields · synced May 30, 2026