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Mammotome® Elite Tetherless Vacuum-Assisted Biopsy System
EUDAMEDFDA UDIClass 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) - Refresh - CE FDA UDI
- Model / Reference
- MEH1 EUDAMEDFDA UDI
- Description
- Holster (tetherless vacuum-assisted biopsy system) - Refresh - CE FDA UDI
Identifiers
- Catalog Number
- CA000687001 FDA UDI
- Primary DI / UDI-DI
- 00841911102823 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 — 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 | 08419111AD01A000003322NP | 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 aac030a8-235f-4180-80ce-00adc2ca1ed1 61 fields · synced Jun 18, 2026
- FDA UDI ad3820d2-dc34-4932-bd48-e910fbe539de 37 fields · synced May 30, 2026