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Semi-automatic Disposable Biopsy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BN-2/162000Model BN-2/140600
Identity
- Trade Name
- Semi-automatic Disposable Biopsy Needle EUDAMEDSureCore Semi-automatic Disposable Biopsy Needle FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- Semi-automatic Disposable Biopsy Needle EUDAMEDFDA UDI
- Model / Reference
- BN-2/140600 EUDAMEDBN-2/162000 EUDAMEDFDA UDI
- Description
- Semi-automatic Disposable Biopsy Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06954414641424 EUDAMEDFDA UDI
- Basic UDI-DI
- 6954414600400001FL EUDAMEDB-06954414641424 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES 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
Semi-automatic Disposable Biopsy Needle by Canyon Medical Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6954414600400001FL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6954414600400001FL | 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 (3)
- EUDAMED 9ce473ee-1112-47ae-b4a5-4c7ff76930c0 61 fields · synced Oct 6, 2026
- EUDAMED 891eac5a-ccf0-4513-a32c-48780a012c3f 61 fields · synced May 17, 2026
- FDA UDI 242492ae-6318-408f-859d-1befa8589587 34 fields · synced May 30, 2026