Identity
- Trade Name
- SIXTUS EUDAMED
- Device Name
- GHIACCIO ISTANTANEO MONOUSO - DISPOSABLE COLD PACK EUDAMED
- Model / Reference
- SF1854SIXGISU EUDAMED
Identifiers
- Primary DI / UDI-DI
- G066SF1854SIXGISU0 EUDAMED
- Basic UDI-DI
- ++G066SFDIS6Z EUDAMED
- Direct Marketing DI
- G066SF1854SIXGISU0 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa 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: Hot/cold therapy pack, reusable
Sixtus by Dispotech srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++G066SFDIS6Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dispotech srl
- EUDAMED SRN
- IT-MF-000010735
Sources (1)
- EUDAMED 8421816b-9a0c-4cb2-8745-7d7b433b47eb 61 fields · synced Jul 8, 2026