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Unit okulistyczny
EUDAMEDFDA UDIClass I (EU MDR)
Ref Eco PlusRef EASY PLUSRef PRO 1000Ref SMART PLUSRef TRU-800Ref PRO 500Ref PRO 1000 EVORef TOROSRef ECO PLUS
Identity
- Trade Name
- Unit okulistyczny EUDAMEDRefraction Unit FDA UDI
- Generic Name
- Ophthalmic examination station FDA UDI
- Device Name
- Unit okulistyczny / Refraction Unit EUDAMEDRefraction Unit / Unit okulistyczny EUDAMED
- Model / Reference
- Eco Plus EUDAMEDFDA UDITOROS EUDAMEDFDA UDIPRO 500 EUDAMEDFDA UDIPRO 1000 EUDAMEDFDA UDITRU-800 EUDAMEDFDA UDISMART PLUS EUDAMEDFDA UDIEASY PLUS EUDAMEDFDA UDIPRO 1000 EVO EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694510 EUDAMEDFDA UDI05907642694435 EUDAMEDFDA UDI05907642694466 EUDAMEDFDA UDI05907642694473 EUDAMEDFDA UDI05907642694565 EUDAMEDFDA UDI05907642694541 EUDAMEDFDA UDI05907642694459 EUDAMEDFDA UDI05907642694480 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694UNIJ9 EUDAMED
- Direct Marketing DI
- 05907642694510 EUDAMED05907642694459 EUDAMED05907642694473 EUDAMED05907642694541 EUDAMED05907642694565 EUDAMED05907642694466 EUDAMED05907642694480 EUDAMED05907642694435 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
Unit okulistyczny by MDT sp. z o.o. — Class I — 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 | 5907642694UNIJ9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MDT sp. z o.o.
- EUDAMED SRN
- PL-MF-000009248
Sources (17)
- EUDAMED fd0e74b7-f9c9-4327-abb9-4e84b5a8a3fa 61 fields · synced Jul 25, 2026
- FDA UDI 32aef791-12d5-4580-a2c8-6ec61ce78445 32 fields · synced May 29, 2026
- FDA UDI 5827f090-3287-4a0b-bf57-265580030d4a 32 fields · synced May 30, 2026
- FDA UDI 157f570d-6882-4f7b-907f-cc587856408d 32 fields · synced May 30, 2026
- FDA UDI eb25f6fd-9ae7-4287-81a7-1674730ba1f0 32 fields · synced May 30, 2026
- FDA UDI 32e8553b-a978-4618-8895-4afe1bbccdd1 32 fields · synced May 30, 2026
- FDA UDI 5a9bbd18-291f-4b1b-aa26-9d8aeb7dc82c 32 fields · synced May 30, 2026
- FDA UDI 2f3b8c80-e921-4aa0-9c3d-fe1c7cd4042a 32 fields · synced May 30, 2026
- FDA UDI c27b7918-5222-4828-8cf5-89b744725787 32 fields · synced May 30, 2026
- EUDAMED 8745029e-cf8b-49cf-be2a-6bb5f04fe136 61 fields · synced Jun 20, 2026
- EUDAMED 141154d3-dde7-42ec-bbf3-b4ec63763c20 61 fields · synced Jul 11, 2026
- EUDAMED ea74f8ad-7bc8-45f4-9dd0-8f62d1392d17 61 fields · synced Jul 11, 2026
- EUDAMED 3a5dbcd0-d266-4fc6-81ea-e265ea84f0e3 61 fields · synced Jul 11, 2026
- EUDAMED c9d585ea-4ede-4ef8-b60f-439f3242fbc7 61 fields · synced Jul 12, 2026
- EUDAMED 27f8a41b-52d0-4396-a2c3-5c684c6557e0 61 fields · synced Jul 19, 2026
- EUDAMED fd1d59f4-921f-4c5e-8ec9-2f562aab33fb 61 fields · synced Jul 22, 2026
- EUDAMED 6c44e7c6-cc6c-4a0b-96c8-2c4cd4c37328 61 fields · synced Jul 25, 2026