Identity
- Trade Name
- SFERA CALC. SING. STRATEGY pz.500 EUDAMED
- Device Name
- Calcinabili EUDAMED
- Model / Reference
- ST04-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224181004 EUDAMED
- Basic UDI-DI
- 805804571CLCK5 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - 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
SFERA CALC. SING. STRATEGY pz.500 by Rhein 83 S.r.l. — 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 | 805804571CLCK5 | Class I | Active |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (1)
- EUDAMED c8f75f7d-8eec-4de7-976a-e1bb76cce4fa 61 fields · synced Jul 15, 2026