← Back to catalogue
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref EVIVA_1210-20
Identity
- Trade Name
- Eviva Stereotactic Guided Breast Biopsy System Biopsy Device EUDAMEDEVIVA_1210-20 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 EUDAMEDPRODUCT, EVIVA, 12 GA, 10 CM LENGTH, 20 MM APERTURE, BOX OF 5 FDA UDI
- Model / Reference
- EVIVA_1210-20 EUDAMEDFDA UDI
- Description
- PRODUCT, EVIVA, 12 GA, 10 CM LENGTH, 20 MM APERTURE, BOX OF 5 FDA UDI
Identifiers
- Catalog Number
- EVIVA_1210-20 FDA UDI
- Primary DI / UDI-DI
- 15420045504981 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVAHANDPCHA EUDAMED
- Direct Marketing DI
- 15420045504981 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180233 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 54200455ATECEVIVAHANDPCHA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000045852
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED b8471cc1-dfb6-4f6b-aaaf-a1dbbcc1a68f 61 fields · synced Jul 16, 2026
- FDA UDI 92a471c6-d42b-47d8-90c4-793cf414c0dc 36 fields · synced May 27, 2026
- FDA 510(k) K180233 1 fields · synced May 18, 2026