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Coaxial Biopsy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CN-17/198Model CN-13/48
Identity
- Trade Name
- Coaxial Biopsy Needle EUDAMEDSureAim Coaxial Biopsy Needle FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- Coaxial Biopsy Needle EUDAMEDFDA UDI
- Model / Reference
- CN-13/48 EUDAMEDCN-17/198 EUDAMEDFDA UDI
- Description
- Coaxial Biopsy Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06954414667523 EUDAMEDFDA UDI
- Basic UDI-DI
- 6954414600500001FZ EUDAMED
- 510(k) Number
- K233031 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Coaxial Biopsy Needle by Canyon Medical Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6954414600500001FZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED d74411fc-3001-4ed2-a4c3-2e364d4be442 61 fields · synced Oct 6, 2026
- FDA UDI 76ba32ce-34c5-4231-b3ca-2813aa16914f 34 fields · synced May 30, 2026