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Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System
EUDAMEDClass IIa (EU MDR)
Ref MRFOOT1
Identity
- Trade Name
- Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System EUDAMED
- Device Name
- Foot switch EUDAMED
- Model / Reference
- MRFOOT1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841911102458 EUDAMED
- Basic UDI-DI
- 08419111AD10B000003322PS EUDAMED
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System by Devicor Medical Products, Inc. — Class IIa — MDR — listed in EUDAMED
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 | 08419111AD10B000003322PS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
- EUDAMED SRN
- US-MF-000003322
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 18bab7bd-5ae0-41a9-96ea-985cd427bd9f 61 fields · synced Oct 6, 2026