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ATEC Breast Biopsy and Excision System Introducer Localization System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ILS 0914-12
Identity
- Trade Name
- ATEC Breast Biopsy and Excision System Introducer Localization System EUDAMEDATEC Introducer FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System - Biopsy Devices and Introducers EUDAMED9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE FDA UDI
- Model / Reference
- ILS 0914-12 EUDAMEDFDA UDI
- Description
- 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE FDA UDI
Identifiers
- Catalog Number
- ILS 0914-12 FDA UDI
- Primary DI / UDI-DI
- 05420045503192 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVAHANDPCHA EUDAMED
- Direct Marketing DI
- 05420045503192 EUDAMED
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Radiological image marker, implantable 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 Conditional FDA UDI
ATEC Breast Biopsy and Excision System Introducer Localization System by Hologic Inc. — 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 | 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 2d61ad16-8858-4ca1-af79-b52e9e1d5df5 61 fields · synced Jun 18, 2026
- FDA UDI cc582297-a209-41fe-8627-e0b4fea34e73 36 fields · synced May 30, 2026