Identity
- Trade Name
- MANI FLARE SPREADERS - 21mm #35 EUDAMED
- Device Name
- MANI SPREADERS EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951505882 EUDAMED
- Basic UDI-DI
- B-04546951505882 EUDAMED4546951000003ZD EUDAMED
- Unit of Use DI
- 74546951505881 EUDAMED
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
No
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 - 21mm #35 by Mani, Inc. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951505882 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951505882 | Class IIa | 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 3200e40a-f26c-4089-bc79-e7ab3ca4b2b5 61 fields · synced Jul 12, 2026
- EUDAMED 001d9985-a923-4f53-bef7-62533941f387 61 fields · synced May 18, 2026