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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 — 69 UDI-DI variants, MDR (HTL-Strefa S.A.)

MD Atlas
HTL-Strefa S.A.

Data from EUDAMED, last updated May 31, 2026

Pen needle

590799609810EFH

69 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: 590799609810EFH
Device name: Pen needle
Device model: Type 810
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Feb 26, 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

69 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01JN12DT1N5KE11G9ZZ0SQT18X

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

415805903999609801
403105903999607241
402505903999607180
414005903999609115
404905903999609610
400305903999606039
415605903999609788
400405903999606046
407305903999607616
403905903999607326
403605903999607296
400705903999606077
407105903999607593
402305903999607166
415105903999608149
402205903999607159
400805903999606084
403205903999607258
403505903999607289
400505903999606053
402905903999607227
411405903999608118
403305903999607265
410905903999607838
408205903999606343

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