Double Spatule Fontana
EUDAMEDFDA UDIClass I (EU MDR)
by Moria S.A.
Identity
- Trade Name
- DOUBLE SPATULE FONTANA EUDAMEDMORIA FDA UDI
- Generic Name
- General-purpose surgical spatula FDA UDI
- Device Name
- WARING IRIS SPATULA EUDAMED
- Model / Reference
- 18070 EUDAMED20028 EUDAMEDFONTANA DOUBLE ENDED SPATULA FDA UDI
Identifiers
- Catalog Number
- 20028 FDA UDI
- Primary DI / UDI-DI
- 03700483609864 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Spatulas1NJ EUDAMED
- Direct Marketing DI
- 03700483609864 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
Double Spatule Fontana by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ocular hook/spatula/manipulator, reusable.
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- Diamatrix — Diamatrix · Class I
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- Ophthalmic Spatula — CILITA Ltd. · Class I
- Rumex — Rumex International Co. · Class I
- Sklar — Sklar Corporation · Class I
- 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 42e6357d-32bb-44e1-bad2-2c905c1c85fa 61 fields · synced Jun 19, 2026
- FDA UDI c8f9009d-8341-4c23-9cd5-9971e772637d 33 fields · synced May 30, 2026