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(Semi)Automatic Biopsy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BIM16/15iModel Biopsy Needle
Identity
- Trade Name
- Semi-automatic Biopsy Needle - BIM16/15i FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- (Semi)Automatic Biopsy Needle EUDAMEDThe biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). FDA UDI
- Model / Reference
- Biopsy Needle EUDAMEDBIM16/15i EUDAMEDFDA UDI
- Description
- The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262410687110 EUDAMEDFDA UDI
- Basic UDI-DI
- 426241068BIMBAM27 EUDAMED
- 510(k) Number
- K233294 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- End-cut biopsy gun handpiece/needle 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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
(Semi)Automatic Biopsy Needle by ITP Innovative Tomography Products GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 426241068BIMBAM27 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
- EUDAMED SRN
- DE-MF-000008634
Sources (2)
- EUDAMED df792d5f-ff54-4030-a019-86c4a7e65eff 61 fields · synced Jul 10, 2026
- FDA UDI 9358c423-05cf-47da-8474-969fcd535627 37 fields · synced May 30, 2026