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Blépharostat Colibri réglable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19078Model 393
by Moria S.A.
Identity
- Trade Name
- Blépharostat Colibri réglable EUDAMEDMORIA FDA UDI
- Generic Name
- Eyelid speculum, reusable FDA UDI
- Device Name
- Pley Speculum adjustable EUDAMED
- Model / Reference
- 393 EUDAMED19078 EUDAMEDAdjustable Colibri Speculum FDA UDI
Identifiers
- Catalog Number
- 19078 FDA UDI
- Primary DI / UDI-DI
- 03700483605651 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Speculums1WX EUDAMED
- Direct Marketing DI
- 03700483605651 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 Colibri réglable 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 1f03fe44-3bfa-436d-981a-0e4cdc39e6a1 61 fields · synced Jul 16, 2026
- FDA UDI 9edb57e0-fb76-47db-aaaf-82797185633f 33 fields · synced May 30, 2026