Identity
- Trade Name
- MANI SURGICAL BURS - 25mm #1559L EUDAMED
- Device Name
- MANI CARBIDE BURS EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951616991 EUDAMED
- Basic UDI-DI
- 4546951000017ZQ EUDAMED
- Unit of Use DI
- 74546951616990 EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class 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
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
MANI SURGICAL BURS - 25mm #1559L by Mani, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 4546951000017ZQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7fe317e2-7a11-40d3-8073-316458febab0 61 fields · synced Jul 25, 2026