Spatule DSAEK à 90°
EUDAMEDFDA UDIClass I (EU MDR)
by Moria S.A.
Identity
- Trade Name
- Spatule DSAEK à 90° EUDAMEDMORIA FDA UDI
- Generic Name
- General-purpose surgical spatula FDA UDI
- Device Name
- WARING IRIS SPATULA EUDAMED
- Model / Reference
- 18070 EUDAMED19077/B EUDAMEDDSAEK Spatula at 90° FDA UDI
Identifiers
- Catalog Number
- 19077/B FDA UDI
- Primary DI / UDI-DI
- 03700483606535 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Spatulas1NJ EUDAMED
- Direct Marketing DI
- 03700483606535 EUDAMED
- FDA Product Code
- HND FDA UDI
- EMDN Code
- L1706 OPHTHALMOLOGY SPATULAS, REUSABLE EUDAMED
- GMDN Term
- General-purpose surgical spatula FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ocular hook/spatula/manipulator, reusable
Spatule DSAEK à 90° by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ocular hook/spatula/manipulator, reusable.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37004836Spatulas1NJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED a4b7e0aa-eb34-444f-ac04-c5cb53808340 61 fields · synced Jun 19, 2026
- FDA UDI 30e2d6f8-5c12-48e8-be31-5ec0b4614b38 33 fields · synced May 30, 2026