Identity
- Trade Name
- POLTRONA RELAX EUDAMED
- Device Name
- POLTRONA RELAX EUDAMED
- Model / Reference
- K05-2R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055773185500 EUDAMED
- Basic UDI-DI
- 805577318POLTRONE-ROLLEC EUDAMED
- EMDN Code
- Y180918 MULTIFUNCTIONAL 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
Yes
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
Category: Assistive ergonomic chair, electrically-adjusted
Poltrona Relax by K S P Italia S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assistive ergonomic chair, electrically-adjusted.
- REAL 9100 PLUS — Mercado Medic AB · Class I
- REAL 9300 PLUS — Mercado Medic AB · Class I
- REAL 9100 PLUS — Mercado Medic AB · Class I
- REAL 9300 PLUS — Mercado Medic AB · Class I
- REAL 9400 PLUS — Mercado Medic AB · Class I
- REAL 9300 PLUS — Mercado Medic AB · Class I
- REAL 9600 PLUS — Mercado Medic AB · Class I
- REAL 9000 PLUS — Mercado Medic AB · Class I
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 | 805577318POLTRONE-ROLLEC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K S P Italia S.r.l.
- EUDAMED SRN
- IT-MF-000009316
Sources (1)
- EUDAMED 81e1bf60-c9fa-42e6-86ea-8811295c7bc1 61 fields · synced Jun 19, 2026