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Diplomat
EUDAMEDClass IIa (EU MDR)
Ref DC 350Model MODEL PRO 800, MODEL PRO 700
Identity
- Trade Name
- DIPLOMAT EUDAMED
- Device Name
- Dental units EUDAMED
- Model / Reference
- MODEL PRO 800, MODEL PRO 700 EUDAMEDDC 350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007067131 EUDAMED
- Basic UDI-DI
- 8588007067DENTALUNITK505C EUDAMED
- Direct Marketing DI
- 08588007067131 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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 delivery system
Diplomat by DIPLOMAT DENTAL s.r.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8588007067DENTALUNITK505C | Class IIa | Active |
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Manufacturer
- Manufacturer
- DIPLOMAT DENTAL s.r.o.
- EUDAMED SRN
- SK-MF-000002562
Sources (1)
- EUDAMED 2289e3f7-6439-436b-8535-c73d92106d56 61 fields · synced Jun 18, 2026