BEUDAMED

EU Manufacturer 🇨🇭 Switzerland Active

Biosensors Europe SA

SRN: CH-MF-000015764 · Rue de Lausanne 29, 1110 Morges, Switzerland

View on EUDAMED

Basic UDI-DIs

185

Total Devices

185

On Market

185

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Rue de Lausanne 29, 1110 Morges, Switzerland
Email: [email protected]
Phone: -
Website: www.biosensors.com

Regulatory Overview

Regulation

Eu Mdd 185

Classification

Eu Md Class 3 185

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Expiry Date
MDD Annex II (excluding section 4)	2116857CE08	DEKRA Certification B.V.	Apr 01, 2024
MDD Annex II Section 4	2116857DE08	DEKRA Certification B.V.	Apr 01, 2024
MDD Annex II Section 4	2116857DE08	DEKRA Certification B.V.	Apr 01, 2024
MDD Annex II (excluding section 4)	252.954	National Standards Authority of Ireland (NSAI)	May 26, 2024
MDD Annex II (excluding section 4)	252.954	National Standards Authority of Ireland (NSAI)	May 26, 2024
MDD Annex II (excluding section 4)	2116857CE05	DEKRA Certification B.V.	Dec 31, 2027
MDD Annex II Section 4	2116857DE04	DEKRA Certification B.V.	Dec 31, 2027
MDD Annex II (excluding section 4)	2116857CE05	DEKRA Certification B.V.	Dec 31, 2027
MDD Annex II Section 4	2116857DE04	DEKRA Certification B.V.	Dec 31, 2027
MDD Annex II Section 4	2116857DE09	DEKRA Certification B.V.	Dec 31, 2027

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS	EU MDD	Eu Md Class 3	On Market	1
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2
CORONARY DRUG ELUTING STENTS (DES) WITHOUT POLYMERS	EU MDD	Eu Md Class 3	On Market	2

View all 185 devices →

PRRC

Name

Orlando Antunes

Country

🇨🇭 Switzerland

Authorized Representative

Name

NVT GmbH

Country

🇩🇪 Germany

Importer

Name

Biosensors BV

Country

🇳🇱 Netherlands

Notified Bodies

DEKRA Certification B.V.

8 certs

National Standards Authority of Ireland (NSAI)

2 certs

Competent Authority

Name

DE/CA40 - Regierungspräsidium Tübingen Referat 25 - Sachgebiet Medizinprodukte

Country

🇩🇪 Germany

More about this competent authority →

Quick Links

Search All Devices