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ATEC Breast Biopsy and Excision System Handpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ATEC 0909-20
Identity
- Trade Name
- ATEC Breast Biopsy and Excision System Handpiece EUDAMEDATEC 0909-20 FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System - Biopsy Devices and Introducers EUDAMED9G (3.7MM) X 9CM, 20MM HANDPIECE FDA UDI
- Model / Reference
- ATEC 0909-20 EUDAMEDFDA UDI
- Description
- 9G (3.7MM) X 9CM, 20MM HANDPIECE FDA UDI
Identifiers
- Catalog Number
- ATEC 0909-20 FDA UDI
- Primary DI / UDI-DI
- 15420045504844 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVAHANDPCHA EUDAMED
- Direct Marketing DI
- 15420045504844 EUDAMED
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Belgium 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 Unsafe FDA UDI
Category: Needle guide, single-use
ATEC Breast Biopsy and Excision System Handpiece by Hologic Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 | 54200455ATECEVIVAHANDPCHA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000045852
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED 1812ac14-5800-48c8-bdab-bfcaf817ae6d 61 fields · synced Jun 18, 2026
- FDA UDI d1fb68b3-79a5-4f62-bb27-f01156a4ae01 36 fields · synced May 30, 2026