← Back to catalogue
(Semi)Automatic Biopsy Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BIM18/20iModel Biopsy NeedleRef BAM18/20Ref BAM18/17Ref BAM16/15
Identity
- Trade Name
- Automatic Biopsy Needle - BAM 18/17 FDA UDIAutomatic Biopsy Needle - BAM 18/20 FDA UDISemi-automatic Biopsy Needle - BIM18/20i FDA UDIAutomatic Biopsy Needle - BAM 16/15 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 EUDAMEDBIM18/20i EUDAMEDFDA UDIBAM16/15 EUDAMEDFDA UDIBAM18/20 EUDAMEDBAM18/17 EUDAMEDBAM 18/17 FDA UDIBAM 18/20 FDA UDI
- Description
- The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262410687011 EUDAMEDFDA UDI04262410686021 EUDAMEDFDA UDI04262410686007 EUDAMEDFDA UDI04262410686106 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 — 175 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDILength — 200 Millimeter FDA UDILength — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
- EUDAMED SRN
- DE-MF-000008634
Sources (8)
- EUDAMED 99e71283-7fb1-4908-bc67-8b0843243689 61 fields · synced Aug 1, 2026
- FDA UDI ace5e1b3-28bd-42eb-b567-bbc212615bde 37 fields · synced May 30, 2026
- FDA UDI 2a7682a7-9d8a-4dd2-bddd-c7d8e32362e0 37 fields · synced May 30, 2026
- FDA UDI 020dc097-bd59-4d40-9deb-b185ba100006 37 fields · synced May 30, 2026
- FDA UDI 79f2ec2f-ec08-4a0f-bdfb-146de3c14c5d 37 fields · synced May 30, 2026
- EUDAMED e04c6f3f-e4fc-4670-b766-8de851621c9f 61 fields · synced Jul 13, 2026
- EUDAMED 3f30f845-ae2d-4e2b-87ee-d5ea215b3eae 61 fields · synced Jul 17, 2026
- EUDAMED 1fcd48ca-4761-41b8-b5bb-e78f29c96838 61 fields · synced Jul 28, 2026