Identity
- Trade Name
- ELMA90BC EUDAMED
- Device Name
- Maniglioni Serie Elegance EUDAMED
- Model / Reference
- ELMA90BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054383332182 EUDAMED
- Basic UDI-DI
- 805438333MANEL000PK EUDAMED
- EMDN Code
- Y181806 HANDLES 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
Elma90bc by Thermomat Saniline S.r.l. — 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 | 805438333MANEL000PK | 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 fd00baa0-cf62-4fa1-b26c-49b09d08f3c0 61 fields · synced Oct 8, 2026