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Bone cutters
EUDAMEDClass IIa (EU MDR)
Ref J02010230 Carbide Bone Cutter (welding)Model Carbide Bone Cutter (welding)
Identity
- Device Name
- Bone cutters EUDAMED
- Model / Reference
- Carbide Bone Cutter (welding) EUDAMEDJ02010230 Carbide Bone Cutter (welding) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978279638016 EUDAMED
- Basic UDI-DI
- 697827963BC002JL EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMEDZ12130503,Z12130580 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Cranial bur, single-use
Bone cutters by WILSON (Shanghai) Medical Device Co., Ltd. — Class IIa — 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 | 697827963BC002JL | Class IIa | Active |
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Manufacturer
- Manufacturer
- WILSON (Shanghai) Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000010527
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED af521fd9-23eb-4853-9db1-e4bd3f0f13fe 61 fields · synced Jun 19, 2026
- EUDAMED 5b2bf375-7384-4f98-a159-86ee8498b039 61 fields · synced Jun 19, 2026