Identity
- Trade Name
- Coaxial Biopsy Needle EUDAMED
- Device Name
- Coaxial Biopsy Needle EUDAMED
- Model / Reference
- CN-13/48 EUDAMEDCN-14/59-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414661156 EUDAMED
- Basic UDI-DI
- 6954414600500001FZ EUDAMED
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Coaxial Biopsy Needle by Canyon Medical Inc. — Class IIa — 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 | 6954414600500001FZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Canyon Medical Inc.
- EUDAMED SRN
- CN-MF-000022663
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1fad48fa-8c6e-487b-ace9-eae58361b526 61 fields · synced May 23, 2026