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ONE-Flow
EUDAMEDClass IIa (EU MDR)
Ref DRMIFTB2Ref DRMIFTA1Ref DRMIFTA2Ref DRMIFTA3
Identity
- Trade Name
- ONE-Flow EUDAMED
- Device Name
- Light curing nano flowable composite EUDAMED
- Model / Reference
- DRMIFTB2 EUDAMEDDRMIFTA1 EUDAMEDDRMIFTA2 EUDAMEDDRMIFTA3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178007148 EUDAMED04772178007100 EUDAMED04772178007117 EUDAMED04772178007124 EUDAMED
- Basic UDI-DI
- 4772178ML-LCNFC26 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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 composite resin
ONE-Flow by UAB "Medicinos linija" — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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 | 4772178ML-LCNFC26 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (4)
- EUDAMED 2764d655-1fa2-47ec-b086-971fb2f20cc4 61 fields · synced Oct 7, 2026
- EUDAMED d80edd35-8af9-4643-88ec-0439c8117d99 61 fields · synced May 17, 2026
- EUDAMED e410f02c-cd34-4445-a426-bc7e0a852168 61 fields · synced May 19, 2026
- EUDAMED 913b7225-bbcf-4d53-9334-ffad7276f16e 61 fields · synced May 19, 2026