BEUDAMED

EU Manufacturer 🇸🇬 Singapore Active

Bioptimal International PTE. LTD.

SRN: SG-MF-000010306 · Jalan Tukang 36, S(619266) Singapore, Singapore

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Basic UDI-DIs

191

Total Devices

191

On Market

191

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Jalan Tukang 36, S(619266) Singapore, Singapore
Email: [email protected]
Website: http://www.bioptimalg.com/en

Regulatory Overview

Regulation

Eu Mdd 191

Classification

Eu Md Class 3 191

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Expired / Withdrawn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)	2181711CE01	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2181711DE02	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2181711DE03	DEKRA Certification B.V.	May 26, 2024
MDD Annex II Section 4	2181711DE01	DEKRA Certification B.V.	May 26, 2024

Market Presence

Devices from this manufacturer are available in 17 countries across Europe.

🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇸 Iceland 🇮🇹 Italy 🇱🇹 Lithuania 🇵🇱 Poland 🇷🇴 Romania 🇸🇮 Slovenia 🇸🇰 Slovakia

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Bipolar Pacing Catheter	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2
Bioptimal Central Venous Catheter and Catherization Kit	EU MDD	Eu Md Class 3	On Market	2

View all 191 devices →

PRRC

Name

Francis Joey Eduave

Country

🇸🇬 Singapore

Authorized Representative #1

Name

Shanghai International Holding Corp. GmbH(Europe)

Country

🇩🇪 Germany

Authorized Representative #2

Name

CMC Medical Devices & Drugs SL

Country

🇪🇸 Spain

Importer #1

Name

ASID BONZ GmbH

Country

🇩🇪 Germany

Importer #2

Name

SC ALPHA MEDICAL SRL

Country

🇷🇴 Romania

Importer #3

Name

Medilex Medical

Country

🇮🇪 Ireland

Importer #4

Name

A.M.I. - Analytical Medical Instruments, s.r.o.

Country

🇨🇿 Czechia

Importer #5

Name

Billmed Sp.zo.o.

Country

🇵🇱 Poland

Importer #6

Name

DISTRIBUCIONES Y REPRESENTACIONES BIOMÉDICAS DIREX, S.L.

Country

🇪🇸 Spain

Importer #7

Name

Bisping Medizintechnik GmbH

Country

🇩🇪 Germany

Importer #8

Name

Sonimed d.o.o.

Country

🇭🇷 Croatia

Notified Bodies

DEKRA Certification B.V.

4 certs

Competent Authority

Name

DE/CA05 - Behorde fur Justiz und Verbraucherschutz

Country

🇩🇪 Germany

More about this competent authority →

Quick Links

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