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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

Optilet PRO lancing device — Class I MDR by DIAGNOSIS S.A.

MD Atlas
DIAGNOSIS S.A.

EUDAMED last updated this device on Aug 7, 2023

Optilet PRO lancing device

590758125lancetdeviceAZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DIAGNOSIS S.A.
UDI-DI code: 05907581259306
Reference / catalog number: 5222

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View device family (Basic UDI)

Manufacturer information

Organization name: DIAGNOSIS S.A.
SRN: PL-MF-000014187
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Jun 30, 2023	Still on market

Device identification

Trade name: Optilet PRO lancing device
UDI-DI code: 05907581259306
Basic UDI-DI: 590758125lancetdeviceAZ
Reference / catalog number: 5222
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Lancing device is a traditional lancing device which shall be used with disposable lancets. The lancing device is intended for use with lancets to puncture the skin and obtain a blood sample from a human body. By turning the rotating knob, the puncture depth can be adjusted by selecting numbers on a depth scale. The obtained blood sample is suitable for medical blood test and blood sampling diabetes. This is a multiple use medical device for use by a single person.
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)05907581259306

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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.

A018099NEEDLES - OTHER ACCESSORIES

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

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.