Identity
- Trade Name
- EVIVA_CALIBRATE_13CM EUDAMEDEviva FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System EUDAMEDPRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA FDA UDI
- Model / Reference
- EVIVA_CALIBRATE_13CM EUDAMEDFDA UDI
- Description
- PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA FDA UDI
Identifiers
- Catalog Number
- EVIVA_CALIBRATE_13CM FDA UDI
- Primary DI / UDI-DI
- 15420045509962 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVACCESS8K EUDAMED
- Direct Marketing DI
- 15420045509962 EUDAMED
- FDA Product Code
- PXP FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mammographic stereotactic biopsy system
Eviva by Hologic, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- ENCOR® — SENORX, INC. · Class II
- Mammotome — Devicor Medical Products, Inc. · Class II
- ENCOR® — SENORX, INC. · Class II
- EleVation™ — Bard Peripheral Vascular · Class II
- Mammotome elite — Devicor Medical Products, Inc. · Class II
- Mammotome revolve — Devicor Medical Products, Inc. · Class II
- Mammotome MR — Devicor Medical Products, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI 745ae598-24ad-4667-8152-010b624736ef 35 fields · synced Jun 19, 2026
- EUDAMED 1b6bf9fd-389a-4a85-8fb5-679b1af82f40 61 fields · synced Jun 19, 2026