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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

GM2012ECVA — Class IIa MDD by BIOPSYBELL SRL

MD Atlas
BIOPSYBELL SRL

EUDAMED last updated this device on Jul 14, 2025

GM2012ECVA

B-08033860003265

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOPSYBELL SRL
UDI-DI code: 08033860003265
Reference / catalog number: GM2012ECVA

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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

No critical warnings reported for this device.

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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: not provided
UDI-DI code: 08033860003265
Basic UDI-DI: B-08033860003265
Reference / catalog number: GM2012ECVA
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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

UDI-DI DataMatrix

Encoded

(01)08033860003265

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EMDN nomenclature code(s)

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

A01020102ASPIRATION FINE NEEDLES AND KITS

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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