Identity
- Trade Name
- NeoBurr EUDAMED
- Device Name
- Tungsten carbide Burs – Pre-Sterile EUDAMED
- Model / Reference
- NEOMAX 2-in-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840221642401 EUDAMED
- Basic UDI-DI
- 08402216NBSMUDP EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
NeoBurr by Microcopy, A Division of Neo-Flo, 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 | 08402216NBSMUDP | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microcopy, A Division of Neo-Flo, Inc.
- EUDAMED SRN
- US-MF-000012637
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7cd8ded2-f506-4a49-a3a5-4c7454e1be70 61 fields · synced Sep 18, 2026