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Bur - 3.18mm, Fluted Ball Gold, 260mm X 5.0mm
EUDAMEDClass IIa (EU MDR)
Ref D26-05031Ref D21-05031
by Zethon Ltd
Identity
- Device Name
- BUR - 3.18MM, FLUTED BALL GOLD, 260MM X 5.0MM EUDAMEDBUR - 3.18MM, FLUTED BALL GOLD, 210MM X 5.0MM EUDAMED
- Model / Reference
- D26-05031 EUDAMEDD21-05031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059358066072 EUDAMED05059358065914 EUDAMED
- Basic UDI-DI
- B-05059358066072 EUDAMEDB-05059358065914 EUDAMED
- EMDN Code
- Z12100985 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bur - 3.18mm, Fluted Ball Gold, 260mm X 5.0mm by Zethon Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05059358066072 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED 8fc121ff-92de-42a8-9335-99ae21154778 61 fields · synced Oct 6, 2026
- EUDAMED 5d35f5fb-a7b5-4a16-8e2a-2b1acaf95b7e 61 fields · synced May 19, 2026