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Blepharostat Oreille Pleine/Plateaux
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17538X10Model 17227X10
by Moria S.A.
Identity
- Trade Name
- BLEPHAROSTAT OREILLE PLEINE/PLATEAUX EUDAMEDONE FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- Kratz wire speculum open blades EUDAMED
- Model / Reference
- 17227X10 EUDAMED17538X10 EUDAMEDSPECULUM SOLID BLADE/ TABS FDA UDI
Identifiers
- Catalog Number
- 17538X10 FDA UDI
- Primary DI / UDI-DI
- 03700483625574 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Speculums2WZ EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Eyelid speculum, single-use 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blepharostat Oreille Pleine/Plateaux by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37004836Speculums2WZ | 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 4712f3a6-8bf2-4f34-8a15-6bbb01d2f076 61 fields · synced Jun 18, 2026
- FDA UDI 8eb284f7-6476-4e4c-88f0-e00c375a1557 33 fields · synced May 30, 2026