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Blépharostat de Barraquer Colibri, bébé
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6346CModel 393
by Moria S.A.
Identity
- Trade Name
- Blépharostat de Barraquer Colibri, bébé EUDAMEDMORIA FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Pley Speculum adjustable EUDAMED
- Model / Reference
- 393 EUDAMED6346C EUDAMEDBarraquer Speculum "Colibri", baby size FDA UDI
Identifiers
- Catalog Number
- 6346C FDA UDI
- Primary DI / UDI-DI
- 03700483607679 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Speculums1WX EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Eyelid speculum, reusable 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Blépharostat de Barraquer Colibri, bébé 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 | 37004836Speculums1WX | 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 532d8fca-6dea-4dc0-99c9-092d3198d77a 61 fields · synced Jul 17, 2026
- FDA UDI 5294c975-5725-4a1d-9fdc-00a4e7177729 33 fields · synced May 30, 2026