Identity
- Trade Name
- CHIROMEGA s.r.o. EUDAMED
- Device Name
- CHIROMEGA 654 DUET EUDAMED
- Model / Reference
- CHIROMEGA 654 DUET EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588009232018 EUDAMED
- Basic UDI-DI
- B-08588009232018 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
CHIROMEGA s.r.o. by Chiromega — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08588009232018 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chiromega
- EUDAMED SRN
- SK-MF-000024150
Sources (1)
- EUDAMED 3e8858b7-9c64-48ff-b2ee-edd7033f58ca 61 fields · synced Jun 18, 2026