Identity
- Trade Name
- Unit okulistyczny EUDAMEDRefraction Unit FDA UDI
- Generic Name
- Ophthalmic examination station FDA UDI
- Device Name
- Refraction Unit / Unit okulistyczny EUDAMED
- Model / Reference
- EASY EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694534 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694UNIJ9 EUDAMED
- Direct Marketing DI
- 05907642694534 EUDAMED
- FDA Product Code
- HMF FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic examination station FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1860 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic examination station
Refraction Unit by Mdt Sp Z O O — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic examination station.
- ILLUMINIX — Illuminix Industries LLC · Class I
- Luxvision — U.S. OPHTHALMIC, L.L.C. · Class I
- Refraction Unit — MDT SP Z O O · Class I
- Refraction Unit — MDT SP Z O O · Class I
- Refraction Unit — MDT SP Z O O · Class I
- Refraction Unit — MDT SP Z O O · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mdt Sp Z O O
Sources (2)
- FDA UDI fecf771c-fc24-4a4e-b0d4-343ec4dc2224 32 fields · synced Jun 18, 2026
- EUDAMED f705d587-2a2e-40ab-905b-a493150e7225 61 fields · synced Jun 18, 2026