Identity
- Trade Name
- Tête Epi-K EUDAMED
- Device Name
- TETE EPI-K EUDAMED
- Model / Reference
- 19390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700483600571 EUDAMED
- Basic UDI-DI
- B-03700483600571 EUDAMED
- EMDN Code
- Z1212020585 MICROKERATOMY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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: Corneal punch set
Tête Epi-K by Moria S.A. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K043183 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03700483600571 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED c5c3a600-c1f4-4ef6-9f5f-25662dbe156d 61 fields · synced Aug 2, 2026
- FDA 510(k) K043183 1 fields · synced May 18, 2026