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CHIROMEGA s.r.o.
EUDAMEDClass IIa (EU MDR)
Ref CHIROMEGA 654 SOLORef CHIROMEGA 654Ref CHIROMEGA 654 NIKAModel CHIROMEGA 654 NikaRef CHIROMEGA 654 CART
by Chiromega
Identity
- Trade Name
- CHIROMEGA s.r.o. EUDAMED
- Device Name
- CHIROMEGA 654 SOLO EUDAMEDCHIROMEGA 654 EUDAMEDCHIROMEGA 654 NIKA EUDAMEDCHIROMEGA 654 CART EUDAMED
- Model / Reference
- CHIROMEGA 654 SOLO EUDAMEDCHIROMEGA 654 EUDAMEDCHIROMEGA 654 Nika EUDAMEDCHIROMEGA 654 CART EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588009232049 EUDAMED08588009232056 EUDAMED08588009232025 EUDAMED08588009232032 EUDAMED
- Basic UDI-DI
- B-08588009232049 EUDAMEDB-08588009232056 EUDAMEDB-08588009232025 EUDAMEDB-08588009232032 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-08588009232049 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chiromega
- EUDAMED SRN
- SK-MF-000024150
Sources (4)
- EUDAMED ed6461a9-c944-4510-b1c1-47aa77a97a14 61 fields · synced Jul 17, 2026
- EUDAMED 5342d1c1-5ca9-482c-8f56-5e7cba21a839 61 fields · synced May 16, 2026
- EUDAMED f7d68658-e4fc-4de4-988a-3ac9d13c0476 61 fields · synced May 17, 2026
- EUDAMED 6f4742bd-9873-4f69-aae1-97360b1d091f 61 fields · synced May 18, 2026