Ophthalmic Electric Table
FDA UDIEUDAMEDClass I (US FDA UDI)
by Mdt Sp Z O O
Identity
- Trade Name
- Okulistyczny stolik elektryczny EUDAMEDOphthalmic Electric Table FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Device Name
- Ophthalmic Electric Table / Okulistyczny stolik elektryczny EUDAMED
- Model / Reference
- RT VF EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694220 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694TABGF EUDAMED
- Direct Marketing DI
- 05907642694220 EUDAMED
- FDA Product Code
- HRJ FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic instrument table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4855 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic instrument table, line-powered
Ophthalmic Electric Table 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 instrument table, line-powered.
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- AIT-W2 — Topcon Healthcare, Inc. · Class I
- S4 OPTIK — Blue.S4 Inc · Class I
- S4 OPTIK — Blue.S4 Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 c5433121-d429-42be-a146-068bc5dec515 32 fields · synced Aug 1, 2026
- EUDAMED 60b301b6-a504-42b9-a0ce-f9ed84e2459b 61 fields · synced Aug 1, 2026