Identity
- Device Name
- Burr, Bohrer EUDAMED
- Model / Reference
- 340-540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049113079042 EUDAMED
- Basic UDI-DI
- 404911314001R002001001RV EUDAMED
- Direct Marketing DI
- 04049113079042 EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
Classification
- Device Class
- Class 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
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: Fluted surgical drill bit, reusable
Burr, Bohrer by ELCON Medical Instruments GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 404911314001R002001001RV | Class I | Active |
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Manufacturer
- Manufacturer
- ELCON Medical Instruments GmbH
- EUDAMED SRN
- DE-MF-000005908
Sources (1)
- EUDAMED fe364a0d-50f0-401d-ac9b-499d78d749b7 61 fields · synced Jul 8, 2026