Optilet Mini lancing device

Organization name

DIAGNOSIS S.A.

SRN

PL-MF-000014187

Manufacturer status

Active

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

• CW135

  EUDAMED did not publish a description for this code.
• CW262

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 3 countries total.

Trade name

Optilet Mini lancing device

UDI-DI code

05907581254028

Basic UDI-DI

590758125lancetdeviceAZ

Reference / catalog number

5221

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• A018099NEEDLES - OTHER ACCESSORIES