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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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Pen needle — 15 UDI-DI variants, MDR (HTL-Strefa S.A.)

MD Atlas
HTL-Strefa S.A.

Data from EUDAMED, last updated May 31, 2026

Pen needle

590799609810046R

15 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: HTL-Strefa S.A.

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Device characteristics

Administers medicine

Identity & classification

Basic UDI-DI: 590799609810046R
Device name: Pen needle
Device model: Type 810.04
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 4, 2026

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

15 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KJWBXY6V67GC5R49HSVMSJB9

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

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779305903999608286
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779805903999608484
779205903999608101
779705903999608477
779005903999607982
779605903999608460
780605903999608620
780305903999608606
780805903999608637
779105903999607999
780705903999608514
779405903999608293
779505903999608309