- Organization name
- UDI-DI code
- Reference / catalog number
US-MF-000003322Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Devicor Medical Products, Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 7, 2026
08419111AD02C000003322RGPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00841911102694
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Netherlands; available across 23 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00841911102694Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08419111AD02C000003322RGMST0809UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
1 packaging level registered — each level carries its own UDI-DI.
00841911102694× 1 unitBase unit10841911102691× 5 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
A019012BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMSNo certificate specifically references this device's Basic UDI-DI.
08419111AD02C000003322RGOn the marketMammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System08419111AD02C000003322RGOn the marketMammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System08419111AD02C000003322RGOn the marketMammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System08419111AD02C000003322RGOn the marketMammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System08419111AD02B000003322QKOn the marketMammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System08419111AD02B000003322QKOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.