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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

Keito Multifunction device — Class IIa MDD by Tuylek, s.l.

MD Atlas
Tuylek, s.l.

EUDAMED last updated this device on Nov 2, 2021

Keito Multifunction device

B-K10A9

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tuylek, s.l.
UDI-DI code: D-K10A9
Reference / catalog number: K10

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Manufacturer information

Organization name: Tuylek, s.l.
SRN: ES-MF-000014584
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Feb 12, 2020	Still on market
Italy	May 10, 2021	Still on market

Device identification

Trade name: Keito Multifunction device
UDI-DI code: D-K10A9
Basic UDI-DI: B-K10A9
Reference / catalog number: K10
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: The KEITO multifunction devices have been designed to perform punctual measurements of basic physiological parameters in public establishments, by automatic and non-invasive methods. They are not designed to issue direct diagnostics nor monitor continuously vital parameters of the patients.
Additional information URL: https://www.keito.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203020501NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

KEITO multifunction deviceB-K973On the market KEITO multifunction deviceB-K10TGYOn the market K8B-K86ZOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.