Identity
- Trade Name
- Operating Table EUDAMEDElectric Operating Table EUDAMED
- Device Name
- Operating Table EUDAMEDElectric Operating Table EUDAMED
- Model / Reference
- ORB-X1N EUDAMEDORB Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440652 EUDAMED06978507780319 EUDAMED
- Basic UDI-DI
- 697548844ORB22TK EUDAMED697850778ORB10U2 EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMEDV08060199 ELECTRIC MEDICAL BEDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Operating Table by Infitek Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697548844ORB22TK | Class I | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000040107
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 6f6fa944-ae08-412d-8015-223a6128f4f9 61 fields · synced Oct 6, 2026
- EUDAMED ce4626e5-0e59-4cfb-b5bb-8eac5bcd87b9 61 fields · synced May 18, 2026