Identity
- Trade Name
- OT EQUATOR PRODENT CLS35 / VCO4 h.2 EUDAMED
- Device Name
- COMPONENTI PER PROTESI FISSA EUDAMED
- Model / Reference
- 030PRCLS352 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224147796 EUDAMED
- Basic UDI-DI
- 805804571MUIMW EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
OT EQUATOR PRODENT CLS35 / VCO4 h.2 by Rhein 83 S.r.l. — 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 | 805804571MUIMW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (1)
- EUDAMED ae7903f8-e8e6-49c5-abdb-9721850624b9 61 fields · synced Sep 30, 2026