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Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System

by Devicor Medical Products, Inc. 4 variants

Ref MRPROBE08

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08419111AD10C000003322QP Basic UDI-DI 00841911103776UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841911103776 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System EUDAMED
Mammotome Prima GUDID
Generic Name
Mammographic stereotactic biopsy system
Device Name
Probe
Model / Ref / Catalog
MRPROBE08, CA000778001
Description
Mammotome Prima MR Disposable Probe - CE
Primary DI / UDI-DI
00841911103776
Basic UDI-DI
08419111AD10C000003322QP
510(k) Number
FDA Product Code
KNW
EMDN Code
A019012 Breast nodules and other structures localisation needles and systems
GMDN Term
Mammographic stereotactic biopsy system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003322
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Devicor Medical Products, Inc.

See all devices from Devicor Medical Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No