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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

MTK1076/FCR1 — Class IIb MDR by BETATEX SPA

MD Atlas
BETATEX SPA

EUDAMED last updated this device on Feb 8, 2024

MTK1076/FCR1

805330078KCVGA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BETATEX SPA
UDI-DI code: 08053300787524
Reference / catalog number: MTK1076/FCR1

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

4 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.
CW007
EUDAMED did not publish a description for this code.
CW001
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	May 26, 2017	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053300787524
Basic UDI-DI: 805330078KCVGA
Reference / catalog number: MTK1076/FCR1
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

UDI-DI DataMatrix

Encoded

(01)08053300787524

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

T0202SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT 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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Certificates

Certificate health across this manufacturer's portfolio.

CVD001823Issued
Technical documentationNotified body: 0373Expiry: Oct 23, 2027
CVD001723Issued
Technical documentationNotified body: 0373Expiry: Oct 23, 2027
CSQ0001220523Supplemented
Quality management systemNotified body: 0373Expiry: Oct 23, 2027