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Ophthalmic Operator's Chair
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OC-1
by Mdt Sp Z O O
Identity
- Trade Name
- Fotel okulistyczny operatora EUDAMEDOphthalmic Operator's Chair FDA UDI
- Generic Name
- Ergonomic surgeon’s chair FDA UDI
- Device Name
- Ophthalmic Operator's Chair / Fotel okulistyczny operatora EUDAMED
- Model / Reference
- OC-1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05907642694602 EUDAMEDFDA UDI
- Basic UDI-DI
- 5907642694OC1EU EUDAMED
- Direct Marketing DI
- 05907642694602 EUDAMED
- FDA Product Code
- HME FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ergonomic surgeon’s chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1140 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: Ergonomic surgeon’s chair
Ophthalmic Operator's Chair by Mdt Sp Z O O — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 325f0907-9b99-4fb7-b140-0a8a1b943ee6 32 fields · synced Jun 20, 2026
- EUDAMED 2f4023dc-c144-4d14-b756-ed9d85a5c09c 61 fields · synced Jun 20, 2026