Identity
- Trade Name
- Brevera Breast Biopsy System Single Chamber Tissue Filter EUDAMEDBrevera Breast Biopsy System FDA UDI
- Generic Name
- General tissue specimen container IVD, fixative/saline FDA UDI
- Device Name
- Brevera Breast Biopsy System EUDAMEDSingle chamber tissue filter assesmbly to collect biopsy core for imaging. FDA UDI
- Model / Reference
- BREVTF01 EUDAMEDFDA UDI
- Description
- Single chamber tissue filter assesmbly to collect biopsy core for imaging. FDA UDI
Identifiers
- Catalog Number
- BREVTF01 FDA UDI
- Primary DI / UDI-DI
- 15420045513761 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455BREVERASYSTA EUDAMED
- Direct Marketing DI
- 15420045513761 EUDAMED
- 510(k) Number
- K163052 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- General tissue specimen container IVD, fixative/saline 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General tissue specimen container IVD, fixative/saline
Brevera Breast Biopsy System by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K163052 also covers:
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI de996e65-d4a4-4e4a-838c-2936577ad133 36 fields · synced Jul 11, 2026
- EUDAMED 2750ca62-993e-4ee9-86ff-0c4bc08e6680 61 fields · synced Jul 11, 2026