Identity
- Trade Name
- THEIA 1.0 EUDAMED
- Device Name
- POLTRONE OPERATORIE EUDAMED
- Model / Reference
- POLTRONE OPERATORIE EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057717403879 EUDAMED
- Basic UDI-DI
- 805771740POOPKQ EUDAMED
- Direct Marketing DI
- 08057717403879 EUDAMED
- EMDN Code
- Z12011201 OPERATING CHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Theia 1.0 by Gardhen Bilance — 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 | 805771740POOPKQ | Class I | Active |
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Manufacturer
- Manufacturer
- Gardhen Bilance
- EUDAMED SRN
- IT-MF-000013019
Sources (1)
- EUDAMED 1b28fde7-9192-4fce-baf8-5d9b654aa96a 61 fields · synced Jun 17, 2026