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Tubulure Evolution 2 - 3 - 3e
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19138
by Moria S.A.
Identity
- Trade Name
- Tubulure Evolution 2 - 3 - 3e EUDAMEDMORIA FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- Evolution 2 - 3 - 3e Tubing EUDAMED
- Model / Reference
- 19138 EUDAMEDEvolution 2-3-3E tubing x10 FDA UDI
Identifiers
- Catalog Number
- 19138 FDA UDI
- Primary DI / UDI-DI
- 03700483600243 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836TubingDV EUDAMED
- FDA Product Code
- HNO FDA UDI
- EMDN Code
- Z1212020585 MICROKERATOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4370 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
Category: Corneal punch set
Tubulure Evolution 2 - 3 - 3e by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 37004836TubingDV | 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 613f4695-2308-4a85-8991-90376781bc48 61 fields · synced Aug 2, 2026
- FDA UDI fd49a735-b2c6-4fe9-bbd0-b167e3d55143 33 fields · synced May 30, 2026