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Ecocel® Nail Lacquer 3, 3ml (IT)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 08430308132813Model TD-05
Identity
- Trade Name
- Ecocel® Nail Lacquer 3,3ml (IT) EUDAMED
- Device Name
- Ecocel® Hydrosoluble nail lacquer 3.3mL EUDAMED
- Model / Reference
- TD-05 EUDAMED08430308132813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430308132813 EUDAMED
- Basic UDI-DI
- B-08430308132813 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Ecocel® Nail Lacquer 3, 3ml (IT) by Polichem SA, Lussemburgo, succursale di Mendrisio — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083087 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08430308132813 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Polichem SA, Lussemburgo, succursale di Mendrisio
- EUDAMED SRN
- CH-MF-000025294
- Authorised Representative
- Almirall S.A. ES-AR-000019145
Sources (2)
- EUDAMED bc7f93d4-275f-49e8-b354-5eb5e403ba9a 61 fields · synced Jul 10, 2026
- FDA 510(k) K083087 1 fields · synced May 18, 2026