Identity
- Trade Name
- Brevera Needle Guide EUDAMED
- Device Name
- Brevera Breast Biopsy System EUDAMED
- Model / Reference
- BREV-NG07L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045515505 EUDAMED
- Basic UDI-DI
- 54200455BREVERASYSTA EUDAMED
- Direct Marketing DI
- 15420045515505 EUDAMED
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Brevera Needle Guide by Hologic Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 54200455BREVERASYSTA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000045852
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED 4776e3cc-25fc-4592-8321-2e4f064098ff 61 fields · synced Jun 20, 2026