Identity
- Trade Name
- Dental Chair EUDAMED
- Device Name
- Dental Chair EUDAMED
- Model / Reference
- ORB-D1000E EUDAMEDORB-D1000P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440782 EUDAMED06975488440805 EUDAMED
- Basic UDI-DI
- 697548844ORBD22XE EUDAMED
- EMDN Code
- V08020199 ELECTRIC MEDICAL CHAIRS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Dental Chair 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 | 697548844ORBD22XE | 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 2c933dc6-4bd0-45ec-9efa-a258ff425c51 61 fields · synced Oct 5, 2026
- EUDAMED 133bde8c-9bf4-430c-9e3a-71dbd428ca89 61 fields · synced May 19, 2026