Identity
- Trade Name
- ETK OT EQUATOR - Hand Screwdriver EUDAMED
- Device Name
- COMPONENTI PER PROTESI FISSA-steli per manipolo EUDAMED
- Model / Reference
- ETK108-AT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224166841 EUDAMED
- Basic UDI-DI
- 805804571CHAJM EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES 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
ETK OT EQUATOR - Hand Screwdriver by Rhein 83 S.r.l. — Class IIa — 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 | 805804571CHAJM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (1)
- EUDAMED fd9cc783-c6c9-4db9-ac5e-68ddf8744441 61 fields · synced Jul 25, 2026