Hier finden Sie die Zertifikate der Hersteller bzw. der Produzenten zu den Produkten in unserm Sortiment. Zum Download des gewünschten Zertifikats klicken Sie bitte den jeweiligen Link in der Spalte "Art des Zertifikats" an.
eu-medical GmbH
| Firma | Produzent | Produkte | Gegenstand der Erklärung | Art des Zertikitats | Verfall |
|---|---|---|---|---|---|
| eu-medical GmbH | - | - | DIN EN ISO 9001:2015 | Qualitätsmanagementsystem, de | 2025/04/12 |
| eu-medical GmbH | - | - | DIN EN ISO 9001:2015 | quality management system, en | 2025/04/12 |
| eu-medical GmbH | - | Gesamtsortiment | EU-Medizinprodukte-Verordnung | EU-MDR Bestätigung | lifetime |
Diabetes Therapie
klinion® diabetes care mit den Produktlinien Klinion Soft fine Plus (Penkanülen) und Klinion Soft Fine Colour (Blutlanzetten)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| Medeco B.V. | - | Klinion Soft Fine Plus | Design, development, control of manufacturing and distribution | ISO 9001:2015 | 2025/02/01 |
| Medeco B.V. | - | Klinion Soft Fine Plus | Design, development, control of manufacturing and distribution | ISO 13485:2016 | 2025/02/01 |
| Medeco B.V. | - | Klinion Soft Fine Plus | Design, manufacture and final inspection of sterile pen needles | FQAS | 2024/05/26 |
| Medeco B.V. | - | Klinion Soft Fine Plus | Medical Devices for wound care and bandages | DOC | 2024/05/26 |
| Medeco B.V. | HTL-Strefa S.A. | Klinion Soft Fine Plus | Design, development, manuf., distr. of blood lancets, pen needles | ISO 13485:2016 | 2025/01/01 |
| Medeco B.V. | HTL-Strefa S.A. | Klinion Soft Fine Colour | Design, development, manuf., distr. of blood lancets, pen needles MDSAP | ISO 13485:2016 MDSAP | 2025/01/01 |
| Medeco B.V. | HTL-Strefa S.A. | Klinion Soft Fine Colour | Sterile, single use blood lancets, pen needles | FQAS | 2024/05/26 |
| Medeco B.V. | HTL-Strefa S.A. | Klinion Soft Fine Colour | CE marked products, specified in the annexed product list | DOC with annex | lifetime of product |
| Medeco B.V. | Genray Hangzhou Life Technology Co., Ltd. | Klinion soft fine plus | Design, development, control of manufacturing and distribution | EN ISO 13485:2016 | 2026/01/01 |
| Medeco B.V. | Genray Hangzhou Life Technology Co., Ltd. | Klinion soft fine plus | Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | CE, EU QMS | 2028/06/01 |
| Medeco B.V. | Genray Hangzhou Life Technology Co., Ltd. | Klinion soft fine plus | EC Declaration of Conformity | DOC | 2028/06/01 |
| Medeco B.V. | Genray Hangzhou Life Technology Co., Ltd. | Klinion soft fine plus | Technical Data Sheet | TDS | lifetime of product |
| Medeco B.V. | Zhejiang Huanyi Sterilistion Technology Co., Ltd. | Klinion soft fine plus | Sterilisation Services | EN ISO 13485:2016 | 2024/06/24 |
| Medeco B.V. | Promisemed Hangzhou Meditech Co., Ltd. | Klinion soft fine lancet | Design, development, control of manufacturing and distribution, QMS | EN ISO 13485:2016 | 2024/10/22 |
| Medeco B.V. | Promisemed Hangzhou Meditech Co., Ltd. | Klinion soft fine lancet | Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | MDR CE | 2025/11/13 |
| Medeco B.V. | Promisemed Hangzhou Meditech Co., Ltd. | Klinion soft fine lancet | EC Declaration of Conformity | DOC | lifetime of product |
| Medeco B.V. | Promisemed Hangzhou Meditech Co., Ltd. | Klinion soft fine lancet | Technical Data Sheet | TDS | lifetime of product |
| Medeco B.V. | Zhejiang Huanyi Irradiation Technology Co., Ltd. | Klinion soft fine lancet | Sterilisation Services | EN ISO 13485:2016 | 2025/01/08 |
| Medeco B.V. | notified body BSI | Mediq Own Brand Products | Transitional provisions for certain medical devices | Statement of Extension CE 607662 | 2028/12/31 |
Becton Dickinson and Company® mit den Produktlinie Thin Wall (Penkanülen), Parallelimport
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| BD and Comp. | - | BD Thin Wall | BD Thin Wall, REF# 320211, 320212, 320213 | DOC | lifetime of product |
diamet® mit den Produktlinien diamet® optima (Blutzuckermesssystem) und diamet® mySafety (Sicherheitspenkanülen und Sicherheitslanzetten)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| SanTecTrade | TaiDoc Techn. | diamet® optima | Blood Glucose Monitoring System | EC FQAS | 2024/05/26 |
| SanTecTrade | TaiDoc Techn. | diamet® optima | Product modelTD-4129 * | DOC | lifetime of product |
| SanTecTrade | HTL-Strefa S.A. | diamet® mySafety | Design, development, manuf., distr. of blood lancets, pen needles | ISO 13485:2016 | 2025/01/01 |
| SanTecTrade | HTL-Strefa S.A. | diamet® mySafety | Sterile, single use blood lancets, pen needles | FQAS | 2024/05/26 |
| SanTecTrade | HTL-Strefa S.A. | diamet® mySafety | CE marked products, specified in the annexed product list | DOC with annex | lifetime of product |
* Herstellererklärung: TaiDoc bezieht sich nicht auf den Namen, sondern auf das Modell. Das diamet optima Blutzuckermessgerät ist das Modell TD-4129. Dies kann man an den Seriennummern der Geräte erkennen. Die Geräteseriennummern fangen alle mit der Modellnummer an.
Medlance® mit der Produktlinie Medlance® plus (Sicherheitslanzetten)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| HTL-Strefa S.A. | HTL-Strefa S.A. | Medlance® plus | Design, development, manuf., distr. of blood lancets, pen needles | ISO 13485:2016 | 2025/01/01 |
| HTL-Strefa S.A. | HTL-Strefa S.A. | Medlance® plus | Design, development, manuf., distr. of blood lancets, pen needles MDSAP | ISO 13485:2016 MDSAP | 2025/01/01 |
| HTL-Strefa S.A. | HTL-Strefa S.A. | Medlance® plus | Sterile, single use blood lancets, pen needles | FQAS | 2024/05/26 |
| HTL-Strefa S.A. | HTL-Strefa S.A. | Medlance® plus | CE marked products, specified in the annexed product list | DOC with annex | lifetime of product |
| HTL-Strefa S.A. | HTL-Strefa S.A. | Medlance® plus | Transitional provisions for certain medical devices | Notified Body Confirmation Letter | 2028/12/31 |
Easy-Soft LITE (Sicherheitslanzetten)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| Novadia Operations GmbH | Ningbo Medsun Medical Co., Ltd. | Easy-Soft LITE | Blood Lancet for Single Use | PQAS, Verfall 2024-05-26 | 2024/05/26 |
wellion® SAFETYLANCETS (Sicherheitslanzetten)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| MED TRUST Handelsges.m.b.H. | keine Angabe | wellion® SAFETYLANCETS | Design, development, manuf., distr. | EN ISO 13485:2016 | 2025/05/01 |
| MED TRUST Handelsges.m.b.H. | keine Angabe | wellion® SAFETYLANCETS | req. of annex V of dir. 93/42/EEC | EC Certificate, 93/42/ECC Annex V, PQAS | 2024/05/26 |
| MED TRUST Handelsges.m.b.H. | keine Angabe | wellion® SAFETYLANCETS | Product Description and Specification, RG0037 | RG0037 | lifetime of product |
| MED TRUST Handelsges.m.b.H. | keine Angabe | wellion® SAFETYLANCETS | DOC, RG0043 | DOC with annex | lifetime of product |
Hautpflege mit der Produktlinie Pedosan®
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| Caremedics B.V. | Bio-Gen Milchserum | Pedosan® | Cosmetic–GMP | DIN EN ISO 22716:2008-12 | 2026/04/30 |
Wundversorgung
klinion® woundcare mit den Produktlinien kliniderm® (moderne Wundauflagen), klinipress® (klassische Wundauflagen), klinifix® (Fixierbinden), kliniplast® (Fixierpflaster), klinidur® (Kompressionsbinden) und klinisoft® (Verbandpolster)
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| Medeco B.V. | - | klinion woundcare | Design, Develop. control of manufacturing and distribution | ISO 9001:2015 | 2025/02/01 |
| Medeco B.V. | - | klinion woundcare | Design, Develop. control of manufacturing and distribution | ISO 13485:2016 | 2025/02/01 |
| Medeco B.V. | - | klinion woundcare | Medical Devices for wound care and intraoperative use | DOC | 2024/05/26 |
| Medeco B.V. | - | klinion woundcare | Medical Devices for wound care and bandages | DOC | lifetime of product |
| Medeco B.V. | Plastod S.p.A | kliniderm foam phmb | Design, production for third parties | ISO 9001:2015 | 2024/07/26 |
| Medeco B.V. | Plastod S.p.A | kliniderm foam phmb | Design, production for third parties | ISO 13485:2016 | 2024/07/26 |
| Medeco B.V. | Plastod S.p.A | kliniderm foam phmb | Sterile and non ssterile advanced wound dressings | FQAS, CE Zertifikat | 2024/05/26 |
| Medeco B.V. | Plastod S.p.A | kliniderm foam phmb | Dressing microbiological control with PHMB and D-Panthenol | DOC | 2024/05/26 |
| Medeco B.V. | Plastod S.p.A | kliniderm foam phmb | Product list kliniderm® foam phmb | Annex to DOC | lifetime of product |
| Medeco B.V. | FARMABAN, s.a. | kliniderm debride / pocket | Sterile single-use devices | DOC | lifetime of product |
| Medeco B.V. | FARMABAN, s.a. | kliniderm debride / pocket | 93/42/EEC directive – Annex II (excl. clause 4) | EC Certificate | 2024/05/27 |
| Medeco B.V. | notified body BSI | Mediq Own Brand Products | Transitional provisions for certain medical devices | Statement of Extension CE 607662 | 2028/12/31 |
Druckpflaster
EUROSTRIPS® emo
| Hersteller | Produzent | Produkte | Gegenstand des Zertifikats | Art des Zertifikats | Verfall |
|---|---|---|---|---|---|
| Eurofarm (S.P.A.) | Eurofarm (S.P.A.) | EUROSTRIPS emo | Quality Management System, Handel | ISO 9001:2015 | 2024/04/24 |
| Eurofarm (S.P.A.) | Eurofarm (S.P.A.) | EUROSTRIPS emo | Quality Management System, Hersteller | ISO 13485:2024 | 2024/04/24 |
| Eurofarm (S.P.A.) | Eurofarm (S.P.A.) | EUROSTRIPS emo | CE Sterile and non-sterile dressings | PQAS | 2024/05/26 |
| Eurofarm (S.P.A.) | Eurofarm (S.P.A.) | EUROSTRIPS emo | Declaration of Conformity EUROSTRIPS EMO STERILE | DOC | lifetime of product |
| Eurofarm (S.P.A.) | Eurofarm (S.P.A.) | EUROSTRIPS emo | Declaration of Conformity EUROSTRIPS EMO STERILE LOT 22/01063 | DOC | 2024/05/26 |
| Eurofarm (S.P.A.) | notified body ICIM S.P.A | EUROSTRIPS emo | Transitional provisions for certain medical devices | Confirmation letter from the notified body | 2028/12/31 |