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OptiSCAN WR
EUDAMEDClass I (EU MDR)
Ref 7098B002Model Intraoral scanner
by CEFLA s.c.
Identity
- Trade Name
- OptiSCAN WR EUDAMED
- Model / Reference
- Intraoral scanner EUDAMED7098B002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837938309 EUDAMED
- Basic UDI-DI
- 803383793IMINTRSC1001D2 EUDAMED
- Direct Marketing DI
- 08033837938309 EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER 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
OptiSCAN WR by CEFLA s.c. — 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 | 803383793IMINTRSC1001D2 | Class I | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (1)
- EUDAMED a0963e0c-4345-4924-abc2-e008e5b1cb89 61 fields · synced Jun 19, 2026