Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SF3064SE_T — Class IIa MDD by BETATEX SPA

MD Atlas
BETATEX SPA

EUDAMED last updated this device on Feb 8, 2024

SF3064SE_T

B-SF3064SE_TSW

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BETATEX SPA
UDI-DI code: D-SF3064SE_TSW
Reference / catalog number: SF3064SE_T

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 18, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-SF3064SE_TSW
Basic UDI-DI: B-SF3064SE_TSW
Reference / catalog number: SF3064SE_T
Issuing entity: EUDAMED

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

D-SF3064SE_TSW

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

Become a partner of MD Atlas

Related devices

SB0039SEB-SB0039SE58On the market MTK1076/FCR1805330078KCVGAOn the market M-connect - CONNECTING TUBE MLL 3WAYS STOPCOCK/FUNNEL 15CMB-WPV0006SS9On the market SE0164SEAB-SE0164SEASPOn the market SF3070SE_TR1805330078KSSHLOn the market

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