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Handle
EUDAMEDClass I (EU MDR)
Ref XCJ01Model XCJ01, XCJ02, XCJ03, XCJ04, XCJ05, XCJ06, XCJ07, XCJ08, XCJ08, XCJ09, XCJ10, XCJ11, XCJ12, XCJ13, XCJ14, XCJ15
Identity
- Device Name
- Handle EUDAMED
- Model / Reference
- XCJ01, XCJ02, XCJ03, XCJ04, XCJ05, XCJ06, XCJ07, XCJ08, XCJ08, XCJ09, XCJ10, XCJ11, XCJ12, XCJ13, XCJ14, XCJ15 EUDAMEDXCJ01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975610800989 EUDAMED
- Basic UDI-DI
- 69756108001000XQ EUDAMED
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, 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
Handle 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 | 69756108001000XQ | 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 (1)
- EUDAMED b0d5bb48-c8fb-4b93-b104-631fa02ce2ae 61 fields · synced Jun 19, 2026