Identity
- Trade Name
- Performer 3 EUDAMED
- Device Name
- Performer 3 EUDAMED
- Model / Reference
- R5100075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M640R51000751001 EUDAMED
- Basic UDI-DI
- ++M640PERFORMER3D9 EUDAMED
- Direct Marketing DI
- +M640R51000751001 EUDAMED
- EMDN Code
- Z1204021501 MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb 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
Performer 3 by Rand S.p.A. — Class IIb — 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 | ++M640PERFORMER3D9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Rand S.p.A.
- EUDAMED SRN
- IT-MF-000013507
Sources (1)
- EUDAMED 97a0440c-2247-4b0e-92e7-17094de0bf48 61 fields · synced Jul 21, 2026