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Eviva Stereotactic Guided Breast Biopsy System Biopsy Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref EVIVA_0913-12
Identity
- Trade Name
- Eviva Stereotactic Guided Breast Biopsy System Biopsy Device EUDAMEDEVIVA 0913-12 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 EUDAMEDPRODUCT, EVIVA, 9 GA, 13 CM LENGTH, 12MM APERTURE FDA UDI
- Model / Reference
- EVIVA_0913-12 EUDAMEDEVIVA 0913-12 FDA UDI
- Description
- PRODUCT, EVIVA, 9 GA, 13 CM LENGTH, 12MM APERTURE FDA UDI
Identifiers
- Catalog Number
- EVIVA 0913-12 FDA UDI
- Primary DI / UDI-DI
- 15420045505322 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVAHANDPCHA EUDAMED
- Direct Marketing DI
- 15420045505322 EUDAMED
- 510(k) Number
- K180233 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
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device 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 f8f438f2-ce44-4cdc-8da1-1612f3e57ae1 61 fields · synced Jun 18, 2026
- FDA UDI ff4d70ae-6aad-4264-8394-bb789c5d1eb6 36 fields · synced May 30, 2026