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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

Version 2.6.0 — Class IIa MDR by Biotechmed S.r.l.

MD Atlas
Biotechmed S.r.l.

EUDAMED last updated this device on Jan 31, 2025

Version 2.6.0

805969359THOLOMEUSJ7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Biotechmed S.r.l.
UDI-DI code: 08059693592608
Reference / catalog number: Version 2.6.0

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View device family (Basic UDI)

Manufacturer information

Organization name: Biotechmed S.r.l.
SRN: IT-MF-000030231
Manufacturer status: Active

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: 08059693592608
Basic UDI-DI: 805969359THOLOMEUSJ7
Reference / catalog number: Version 2.6.0
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

UDI-DI DataMatrix

Encoded

(01)08059693592608

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EMDN nomenclature code(s)

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

Z12039092VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE

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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Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

IT326369Issued
Quality management systemNotified body: 1370Expiry: Oct 17, 2028