Statistics for HTL-Strefa S.A.

310Total Devices

153Basic UDI-DIs

0Not destined for EU market

1Certificates

1Valid

0Expiring < 6 months

20Countries

Certificate health for HTL-Strefa S.A.

Devices by risk class

Device catalog for HTL-Strefa S.A.

No devices registered for this manufacturer.

Market presence of HTL-Strefa S.A.

Devices placed in 20 countries

Italy44
Germany43
Poland40
France26
Spain23
Czechia17
Lithuania17
Denmark14
Latvia13
Netherlands13
Sweden11
Estonia10
Finland10
Slovenia10

MD Atlas update: May 31, 2026

HTL-Strefa S.A.

PL-MF-000002198

Active

Address: Adamówek, 7 95-035 Ozorków
Role: Manufacturer
Date of registration: Mar 18, 2021
Country: PL Poland

Device catalog for HTL-Strefa S.A.

No devices registered for this manufacturer.

Devices by risk class

About HTL-Strefa S.A.

SRN: PL-MF-000002198
Role: Manufacturer
Country: Poland
Organization name: HTL-Strefa S.A.
EU VAT number: 732-18-80-362
EORI: PL732188036200000
Trade register: 0000256309
Date of registration: Mar 18, 2021

Contact details for HTL-Strefa S.A.

Address: 7, ADAMÓWEK 95-035 OZORKÓW POLAND
Phone: +48 664140189
Email: justyna.zemigala@htl-strefa.pl
Website: www.htl-strefa.com

Validator

Name: Urząd Rejestracji Produktów Leczniczych
SRN: PL-CA-014
Phone: +48 22 492 11 71
Email: wm@urpl.gov.pl

Officers and regulatory representatives of HTL-Strefa S.A.

ŻEMIGAŁA Justyna
Ensuring: the conformity of the device as per QMS, before release; technical documentation, declaration of conformity; PMS; Vigilance; in the case of investigational devices, statement referred to in Sec. 4.1 of Chapter II of Annex XV is issued.
Hidden

Market presence of HTL-Strefa S.A.

Devices placed in 20 countries

Italy44
Germany43
Poland40
France26
Spain23
Czechia17
Lithuania17
Denmark14
Latvia13
Netherlands13
Sweden11
Estonia10
Finland10
Slovenia10

Belgium4

Hungary4

Norway4

Portugal4

Austria2

Slovakia1

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Statistics for HTL-Strefa S.A.

310Total Devices

153Basic UDI-DIs

0Not destined for EU market

1Certificates

1Valid

0Expiring < 6 months

20Countries

Statistics for HTL-Strefa S.A.

Certificate health for HTL-Strefa S.A.

Devices by risk class

Device catalog for HTL-Strefa S.A.

Device families (Basic UDI-DI) of HTL-Strefa S.A.

Market presence of HTL-Strefa S.A.

HTL-Strefa S.A.

Device catalog for HTL-Strefa S.A.

Devices by risk class

About HTL-Strefa S.A.

Contact details for HTL-Strefa S.A.

Validator

Officers and regulatory representatives of HTL-Strefa S.A.

Market presence of HTL-Strefa S.A.

Statistics for HTL-Strefa S.A.

Certificate health for HTL-Strefa S.A.

Device families (Basic UDI-DI) of HTL-Strefa S.A.