Identity
- Trade Name
- TETE M2 110 EUDAMEDMORIA FDA UDI
- Generic Name
- Microkeratome FDA UDI
- Device Name
- TETE M2 110 EUDAMED
- Model / Reference
- 19327/110 EUDAMEDM2 HEAD 110 FDA UDI
Identifiers
- Catalog Number
- 19327/110 FDA UDI
- Primary DI / UDI-DI
- 03700483608393 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700483608393 EUDAMED
- FDA Product Code
- HMY FDA UDI
- EMDN Code
- Z1212020599 MICROKERATOMY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microkeratome FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4370 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
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tete M2 110 by Moria S.A. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700483608393 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED fbf0eb51-badd-4697-b4bb-3fac5b183a07 61 fields · synced Jul 14, 2026
- FDA UDI 05a91f07-033a-4314-b956-394230519f72 33 fields · synced May 30, 2026