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Guide Device
EUDAMEDClass I (EU MDR)
Ref XCF05Model XCF01, XCF02, XCF03, XCF04, XCF05, XCF06, XCF07
Identity
- Device Name
- Guide Device EUDAMED
- Model / Reference
- XCF01, XCF02, XCF03, XCF04, XCF05, XCF06, XCF07 EUDAMEDXCF05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975610800637 EUDAMED
- Basic UDI-DI
- 69756108000600YF EUDAMED
- EMDN Code
- L0920 ORTHOPAEDIC SURGERY DISTRACTORS, 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
Guide Device 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 | 69756108000600YF | 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 6be06f7d-1dca-4624-bf57-8d69b7bb8053 61 fields · synced Jun 19, 2026