Identity
- Trade Name
- ATEC STX-2 EUDAMEDATEC FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System EUDAMED
- Model / Reference
- ATEC STX-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045509832 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVACCESS8K EUDAMED
- Direct Marketing DI
- 15420045509832 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
Atec 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.
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- 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 bca03c07-5773-4788-8bb5-b4795a22b182 32 fields · synced Jul 18, 2026
- EUDAMED 8068b8de-a458-4279-a993-d3db7103cecc 61 fields · synced Jul 18, 2026