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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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Personal lancet — 1 UDI-DI variant, MDD (HTL-Strefa S.A.)

MD Atlas
HTL-Strefa S.A.

Data from EUDAMED, last updated May 31, 2026

Personal lancet

B-05903999607388

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: HTL-Strefa S.A.

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 84587CE01
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TÜV Rheinland LGA Products GmbH (0197)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-05903999607388
Device name: Personal lancet
Device model: Type 560
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Nov 20, 2025

Manufacturer & authorised representative

Manufacturer

Name: HTL-Strefa S.A.
SRN: PL-MF-000002198
Country: Poland
Email: justyna.zemigala@htl-strefa.pl
Phone: +48 664140189

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KAGCPP5YV3Z7W4JX7JQX6BB0

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

962705903999607388