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Osteotome
EUDAMEDClass I (EU MDR)
Ref XCC03Model XCC01, XCC02, XCC03, XCC04Ref XCC02Ref XCC04Ref XCC01
Identity
- Device Name
- Osteotome EUDAMED
- Model / Reference
- XCC01, XCC02, XCC03, XCC04 EUDAMEDXCC03 EUDAMEDXCC02 EUDAMEDXCC04 EUDAMEDXCC01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975610800194 EUDAMED06975610800187 EUDAMED06975610800200 EUDAMED06975610800170 EUDAMED
- Basic UDI-DI
- 69756108000300XY EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Osteotome by Changzhou Centrau Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69756108000300XY | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Centrau Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027491
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (4)
- EUDAMED a38db96c-6b8b-4ac1-90b2-40b314db7bee 61 fields · synced Oct 6, 2026
- EUDAMED 3b8406c1-8e85-4a1b-a783-f4785738cc55 61 fields · synced May 17, 2026
- EUDAMED 7782966c-aedd-448c-ad64-ed44d888757c 61 fields · synced May 19, 2026
- EUDAMED 62697537-3ad4-4529-8bdc-039b0e1acfc7 61 fields · synced May 19, 2026