Identity
- Trade Name
- SURGERIL EUDAMED
- Device Name
- Trattamento Crioterapico Fibromi Penduli 50ml EUDAMED
- Model / Reference
- SUR0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032779840466 EUDAMED
- Basic UDI-DI
- 803277984SURGERILR5 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
Surgeril by Sixtem Life 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 | 803277984SURGERILR5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sixtem Life Srl
- EUDAMED SRN
- IT-MF-000022977
Sources (1)
- EUDAMED be83b6a9-5f64-47c4-8823-620f68a2eae7 61 fields · synced Jul 8, 2026