Identity
- Trade Name
- The Morgan mor-FLEX Lens EUDAMEDMorTan FDA UDI
- Generic Name
- Eye irrigation shield, single-use FDA UDI
- Device Name
- The Morgan mor-FLEX Lens EUDAMEDFDA UDI
- Model / Reference
- MT6673 EUDAMEDFDA UDI
- Description
- The Morgan mor-FLEX Lens FDA UDI
Identifiers
- Primary DI / UDI-DI
- B090MT66730 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B090MT6673NY 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
- 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
Yes
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
The Morgan mor-FLEX Lens by ZIEN Medical Technologies, LLC — Class IIa — 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 | ++B090MT6673NY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
- EUDAMED SRN
- US-MF-000004717
- Authorised Representative
- Medical Workshop BV NL-AR-000012616
Sources (2)
- EUDAMED 49bae746-3b5b-4da3-8556-f890e9537745 61 fields · synced Oct 6, 2026
- FDA UDI aa053315-c5f9-4e30-be21-afa58fa5c432 33 fields · synced May 30, 2026