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ATEC Breast Biopsy and Excision System Ultrasound Introducer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AI120920
Identity
- Trade Name
- ATEC Breast Biopsy and Excision System Ultrasound Introducer 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 EUDAMEDINTRODUCER, ULTRASOUND, 1209-20, ATEC FDA UDI
- Model / Reference
- AI120920 EUDAMEDFDA UDI
- Description
- INTRODUCER, ULTRASOUND, 1209-20, ATEC FDA UDI
Identifiers
- Catalog Number
- AI120920 FDA UDI
- Primary DI / UDI-DI
- 15420045504585 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVAHANDPCHA EUDAMED
- Direct Marketing DI
- 15420045504585 EUDAMED
- 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
Yes
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
ATEC Breast Biopsy and Excision System Ultrasound Introducer 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 349314f0-8415-4975-928f-75b7d456629e 61 fields · synced Jun 18, 2026
- FDA UDI 18f12a4e-6380-4f88-a877-2a8b4f886b21 35 fields · synced May 30, 2026