Identity
- Trade Name
- LETTINO AMALTHEA EUDAMED
- Device Name
- AMALTHEA EUDAMED
- Model / Reference
- SERIE PROFESSIONAL EUDAMED1111H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80505939405132 EUDAMED80505939405064 EUDAMED
- Basic UDI-DI
- 8050593941111HSJ EUDAMED
- Direct Marketing DI
- 80505939405132 EUDAMED80505939405064 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - 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
Lettino Amalthea by FISIOTECH srl — 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 | 8050593941111HSJ | Class I | Active |
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Manufacturer
- Manufacturer
- FISIOTECH srl
- EUDAMED SRN
- IT-MF-000028185
Sources (2)
- EUDAMED 0e6ff068-5dfe-43d4-8372-54cc5b24b827 61 fields · synced Aug 2, 2026
- EUDAMED 2b20c419-8b2b-40f3-92b8-b43d5ddd1cf9 61 fields · synced May 19, 2026