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Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MEP10
Identity
- Trade Name
- Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System EUDAMEDMammotome elite FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Probe EUDAMEDElite Probe - Refresh FDA UDI
- Model / Reference
- MEP10 EUDAMEDFDA UDI
- Description
- Elite Probe - Refresh FDA UDI
Identifiers
- Catalog Number
- CA000137013 FDA UDI
- Primary DI / UDI-DI
- 00841911102793 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD01B000003322PL 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
- Side-notch biopsy gun handpiece/needle 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 13.4 Centimeter FDA UDINeedle Gauge — 10 Gauge FDA UDI
Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System by Devicor Medical Products, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08419111AD01B000003322PL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
- EUDAMED SRN
- US-MF-000003322
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED c7713457-bb15-40ae-8bcd-2754677edd63 61 fields · synced Jul 20, 2026
- FDA UDI 8f7f64fb-4d18-4305-9f19-479d6adb1ec2 37 fields · synced May 30, 2026