Identity
- Trade Name
- 355-B EUDAMED
- Device Name
- Specchio Reclinabile Serie Verniciata EUDAMED
- Model / Reference
- 355-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055349488141 EUDAMED
- Basic UDI-DI
- 805534948SPEVR000DQ EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER 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
Category: Hydrotherapy bath/tank
355-B by Thermomat Saniline S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hydrotherapy bath/tank.
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- CRYSTAL ELECTRIQUE — France Reval · Class I
- Harmony Bath — Arjohuntleigh, Inc. · Class II
- commode chair — Zhenjiang U-Nurse Medical Equipment Co.,Ltd · Class I
- Primo — Arjohuntleigh, Inc. · Class II
- Primo Ferro — Arjohuntleigh, Inc. · Class II
- Primo — Arjohuntleigh, Inc. · Class II
- Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · 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 | 805534948SPEVR000DQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermomat Saniline S.r.l.
- EUDAMED SRN
- IT-MF-000051936
Sources (1)
- EUDAMED 1b0de131-8dbc-41fc-8752-22ed6ed39eaf 61 fields · synced Jun 19, 2026