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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

ORSI GUN — Class IIa MDR by BIOPSYBELL SRL

MD Atlas
BIOPSYBELL SRL

EUDAMED last updated this device on Apr 7, 2026

ORSI GUN

8033860BIOEFT01U5

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOPSYBELL SRL
UDI-DI code: 08033860003180
Reference / catalog number: GUN1810ECISO

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOPSYBELL SRL
SRN: IT-MF-000011601
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

IT349638Issued
Quality assuranceNotified body: 1370Expiry: Feb 9, 2030

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: ORSI GUN
UDI-DI code: 08033860003180
Basic UDI-DI: 8033860BIOEFT01U5
Reference / catalog number: GUN1810ECISO
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A0102010102SHEARING BIOPSY GUNS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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