Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMEDMammotome Revolve EX FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Holster EUDAMEDRevolve EX Ultrasound Holster - CE FDA UDI
- Model / Reference
- MHEXH1 EUDAMEDFDA UDI
- Description
- Revolve EX Ultrasound Holster - CE FDA UDI
Identifiers
- Catalog Number
- CA000503001 FDA UDI
- Primary DI / UDI-DI
- 00841911102335 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02B000003322QK EUDAMED
- 510(k) Number
- K202012 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
No
FDA UDI
Category: Mammographic stereotactic biopsy system
Mammotome Revolve EX by Devicor Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
- ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- Eviva — Hologic, Inc. · Class I
- ENCOR® — SENORX, INC. · Class II
- Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
- ENCOR® — SENORX, INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
Sources (2)
- FDA UDI d5790a94-ae6b-48b4-820c-40b000532edd 35 fields · synced Jun 11, 2026
- EUDAMED 4e3603f7-7759-4e8d-95c3-7cefc241d64f 61 fields · synced Jun 11, 2026