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Full Core Disposable Biopsy Needle
EUDAMEDClass IIa (EU MDR)
Ref FBN-2/2010Model FBN-2/1407
Identity
- Trade Name
- Full Core Disposable Biopsy Needle EUDAMED
- Device Name
- Full Core Disposable Biopsy Needle EUDAMED
- Model / Reference
- FBN-2/1407 EUDAMEDFBN-2/2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414671902 EUDAMED
- Basic UDI-DI
- 6954414600700002GV EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES 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
Full Core Disposable 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 | 6954414600700002GV | 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 7f3c2f08-6650-43a8-9f63-f5c77c31f0c4 61 fields · synced Jun 19, 2026