Identity
- Trade Name
- OT EQUATOR ANALOG for lab, 2 pcs EUDAMED
- Device Name
- ANALOGHI SPAZIATORI EUDAMED
- Model / Reference
- 144.AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059224115665 EUDAMED
- Basic UDI-DI
- 805804571ANLKK EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY 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: Dental implant suprastructure, temporary, preformed, single-use
OT EQUATOR ANALOG for lab, 2 pcs by Rhein 83 S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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 | 805804571ANLKK | Class I | Active |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (1)
- EUDAMED 32e79292-0884-43da-b910-deccdf449c5e 61 fields · synced Jun 19, 2026