Identity
- Trade Name
- BIOFAMILY FASCIA FREDDO E CALDO EUDAMED
- Device Name
- DISPOSITIVI IN NEOPRENE EUDAMED
- Model / Reference
- BF0017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08013366000197 EUDAMED
- Basic UDI-DI
- 80312550009K4 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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: Device sterilization/disinfection container, reusable
Biofamily Fascia Freddo E Caldo by Phyto Performance Italia Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Freddo / Caldo
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 | 80312550009K4 | Class I | Active |
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Manufacturer
- Manufacturer
- Phyto Performance Italia Srl
- EUDAMED SRN
- IT-MF-000008118
Sources (1)
- EUDAMED 9e85b10f-0a0d-4b79-beb2-4b8706bde376 61 fields · synced Jun 19, 2026