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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

MTK0026 — Class IIb MDR by BETATEX SPA

MD Atlas
BETATEX SPA

EUDAMED last updated this device on Apr 11, 2024

MTK0026

805330078SBSH9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BETATEX SPA
UDI-DI code: 08053807810329
Reference / catalog number: MTK0026

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View device family (Basic UDI)

Manufacturer information

Organization name: BETATEX SPA
SRN: IT-MF-000009955
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

CVD001823Issued
Technical documentationNotified body: 0373Expiry: Oct 23, 2027
CVD001723Issued
Technical documentationNotified body: 0373Expiry: Oct 23, 2027

Critical warnings

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

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.
CW018
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	Nov 30, 2022	Apr 10, 2024

Device identification

Trade name: not provided
UDI-DI code: 08053807810329
Basic UDI-DI: 805330078SBSH9
Reference / catalog number: MTK0026
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

A02010799PREFILLED SYRINGES - OTHER

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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