Gamma

by Biopsybell SRL 76 variants

Ref GM2225EC

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberIT349638	Date10 Feb 2026Issued	StatusWithdrawn expires 9 Feb 2030 withdrawn 15 Jun 2026
European Union	CE/MDR	Number8033860BIOEFT01U5 Basic UDI-DI 08033860003425UDI-DI	Date20 Jan 2026Registered	StatusActive

Certificates

1 certificate · EUDAMED

IT349638 Withdrawn

Quality assurance EU MDR

Certifier

BUREAU VERITAS ITALIA S.P.A. 1370

Issued
10 Feb 2026

Expires
9 Feb 2030

Reason
Other

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Needles for Biopsy or Explant
Model / Reference: GM2225EC

Primary DI / UDI-DI: 08033860003425
Basic UDI-DI: 8033860BIOEFT01U5, B-08033860003425
EMDN Code: A01020102 Aspiration fine needles and kits

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000011601

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Properties

Sterile

Other properties (12)

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