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Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref MEH1
Identity
- Trade Name
- Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System EUDAMEDMammotome elite FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Holster EUDAMEDHolster (tetherless vacuum-assisted biopsy system) - CE FDA UDI
- Model / Reference
- MEH1 EUDAMEDFDA UDI
- Description
- Holster (tetherless vacuum-assisted biopsy system) - CE FDA UDI
Identifiers
- Catalog Number
- MEH1 FDA UDI
- Primary DI / UDI-DI
- 00841911100850 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD01A000003322NP EUDAMED
- 510(k) Number
- K153709 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System by Devicor Medical Products, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112411 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08419111AD01A000003322NP | 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 (3)
- EUDAMED 141e0b98-062e-461e-9879-8a453cc64624 61 fields · synced Jun 18, 2026
- FDA UDI bedaff40-f2ba-49d3-8f8d-6e71f20d0c87 37 fields · synced May 30, 2026
- FDA 510(k) K112411 1 fields · synced May 18, 2026