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Electrical Surgical Bone Saws (machine only)
EUDAMEDClass IIa (EU MDR)
Ref SP-002-3
Identity
- Device Name
- Electrical Surgical Bone Saws (machine only) EUDAMED
- Model / Reference
- SP-002-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181642762 EUDAMED
- Basic UDI-DI
- B-06973181642762 EUDAMED
- EMDN Code
- Z12130502 ORTHOPAEDIC SURGICAL SAWS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Electrical Surgical Bone Saws (machine only) by Dongguan Kaiser Technology Co., 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-06973181642762 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan Kaiser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000006968
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 2770ec58-e0a3-411a-bd38-5eb1d4ccfa11 61 fields · synced Aug 1, 2026