Ecarteur de Wolkmann à 4 griffes
EUDAMEDFDA UDIClass I (EU MDR)
by Moria S.A.
Identity
- Trade Name
- Ecarteur de Wolkmann à 4 griffes EUDAMEDMORIA FDA UDI
- Generic Name
- Periocular/lacrimal retractor, hand-held, reusable FDA UDI
- Device Name
- Wolkmann Retractor with 4 prongs EUDAMED
- Model / Reference
- 1353 EUDAMEDWolkmann Retractor with 4 prongs FDA UDI
Identifiers
- Catalog Number
- 1353 FDA UDI
- Primary DI / UDI-DI
- 03700483604104 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836RetractorsXJ EUDAMED
- Direct Marketing DI
- 03700483604104 EUDAMED
- FDA Product Code
- HNI FDA UDI
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Periocular/lacrimal retractor, hand-held, 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
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
The Ecarteur de Wolkmann à 4 griffes is a medical device that uses a unique Wolkmann Retractor mechanism to facilitate precise and safe tissue manipulation, making it an ideal tool for various medical applications. This device is designed for sterile use and features a user-friendly interface with multiple components.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37004836RetractorsXJ | 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 761768a1-8c53-4433-9980-5678098b3814 61 fields · synced Jul 18, 2026
- FDA UDI 7adce4cb-e1ef-4cdd-a3b1-9ede61a345b6 33 fields · synced May 30, 2026