Identity
- Trade Name
- MANI FLARE SPREADERS - 25mm #30 EUDAMED
- Device Name
- MANI SPREADERS EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951505943 EUDAMED
- Basic UDI-DI
- 4546951000003ZD EUDAMEDB-04546951505943 EUDAMED
- Unit of Use DI
- 74546951505942 EUDAMED
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
MANI FLARE SPREADERS - 25mm #30 by Mani, Inc. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4546951000003ZD | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4546951000003ZD | Class I | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 41e183db-0445-4ef7-bea6-165a89206102 61 fields · synced Jul 31, 2026
- EUDAMED 2b9749ac-60a7-414a-94af-79c1f0d1c297 61 fields · synced May 19, 2026