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Anneau M2 Large Cut -1
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 19379/-1
by Moria S.A.
Identity
- Trade Name
- ANNEAU M2 LARGE CUT -1 EUDAMEDMORIA FDA UDI
- Generic Name
- Microkeratome FDA UDI
- Device Name
- ANNEAU M2 LARGE CUT -1 EUDAMED
- Model / Reference
- 19379/-1 EUDAMEDM2 SUCTION LARGE CUT RING -1 FDA UDI
Identifiers
- Catalog Number
- 19379/-1 FDA UDI
- Primary DI / UDI-DI
- 03700483608478 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700483608478 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Anneau M2 Large Cut -1 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-03700483608478 | 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 7287d4a8-853f-4ff4-8e83-fae3ef8c2176 61 fields · synced Jul 25, 2026
- FDA UDI 97fbd9a5-79cc-48a6-a9f9-447c00274421 33 fields · synced May 30, 2026