Identity
- Device Name
- Template EUDAMED
- Model / Reference
- XCK01, XCK02, XCK03 EUDAMEDXCK01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975610801139 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 (1)
- EUDAMED ddb49d9b-a692-41aa-a82c-8fba877c8b6d 61 fields · synced Jun 18, 2026