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Bur - 3.18mm, Fluted Ball Gold, 210mm X 7.5mm
EUDAMEDClass IIa (EU MDR)
Ref D21-07531
by Zethon Ltd
Identity
- Device Name
- BUR - 3.18MM, FLUTED BALL GOLD, 210MM X 7.5MM EUDAMED
- Model / Reference
- D21-07531 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059358065952 EUDAMED
- Basic UDI-DI
- B-05059358065952 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, 210mm X 7.5mm 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-05059358065952 | 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 (1)
- EUDAMED aa818408-c1ae-4488-ad15-5f547034222d 61 fields · synced Jul 22, 2026