Identity
- Device Name
- Template EUDAMED
- Model / Reference
- XCK01, XCK02, XCK03 EUDAMEDXCK03 EUDAMEDXCK02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975610801153 EUDAMED06975610801146 EUDAMED
- Basic UDI-DI
- 69756108001100XV EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Template 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 | 69756108001100XV | 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 (2)
- EUDAMED c6cc8798-fae4-45f9-8ade-72e141292187 61 fields · synced Aug 1, 2026
- EUDAMED 1905be16-25e3-4b9d-951e-30bbaed3ed5a 61 fields · synced May 19, 2026