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The Morgan mor-FLEX Lens
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MT6673
by MorTan, Inc.
Identity
- Trade Name
- The Morgan mor-FLEX Lens FDA UDI
- Generic Name
- Eye irrigation shield, single-use FDA UDI
- Device Name
- The Morgan mor-FLEX Lens EUDAMEDOcular irrigation system FDA UDI
- Model / Reference
- MT6673 EUDAMEDFDA UDI
- Description
- Ocular irrigation system FDA UDI
Identifiers
- Primary DI / UDI-DI
- M170MT66730 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M170MT66730 EUDAMED
- FDA Product Code
- KYG FDA UDI
- EMDN Code
- A03040202 OCULAR IRRIGATION KITS, SINGLE-USE EUDAMED
- GMDN Term
- Eye irrigation shield, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4360 FDA UDI
- Market of Registration
- Denmark 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Radiation Sterilization FDA UDI
The Morgan mor-FLEX Lens by MorTan, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-M170MT66730 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MorTan, Inc.
- EUDAMED SRN
- US-MF-000017245
- Authorised Representative
- Medical Workshop BV NL-AR-000012616
Sources (2)
- EUDAMED 682a12f0-5635-4740-8968-bf893d32e5cc 61 fields · synced Jun 19, 2026
- FDA UDI 83e2c0c9-c66e-4d69-b717-05f895db20ec 34 fields · synced May 30, 2026