EU Manufacturer 🇩🇪 Germany Active

BIOEUROPE GmbH

SRN: DE-MF-000039230 · Europaplatz 1, 88131 Lindau, Germany
Basic UDI-DIs
18
Total Devices
18
On Market
18
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1

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Basic Information

Address
Europaplatz 1, 88131 Lindau, Germany

Regulatory Overview

Regulation
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Eu Ivdd 17
Eu Ivdr 1
Classification
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Eu Ivd General 12
Eu Ivd Self Testing 4
Eu Ivd Class B 1
Eu Ivd Annex 2 List B 1
Device Types
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Certificate Health

Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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Type Number Expiry Date Status
IVDD Annex IV (excluding sections 4, 6) 22823 May 26, 2025

Market Presence

Devices from this manufacturer are available in 1 country across Europe.

🇩🇪 Germany

Device Portfolio

Name
Bioeurope 14 Food Intolerance Test (ref:7182)
Bioeurope 14 Food Intolerance Test (ref:7194)
Bioeurope 4 Food Intolerance Test (ref:7184)
Bioeurope 4 Food Intolerance Test (ref:7187)
Bioeurope 42 Food Intolerance Test (ref:7179)
Bioeurope 7 Food Intolerance Test (ref:7181)
Bioeurope 7 Food Intolerance Test (ref:7189)
Bioeurope 90 Food Intolernace Test (ref:7180)
EZ-Microalbumin Screening Test
Fortel Kidney Disease (Microalbumin) Screening Test
Fortel Prostate (PSA) Screening Test
Fortel Ulcer (H. pylori) Screening Test
Fortel Ultra Sensitive Pregnancy Midstream 1-Test
Fortel Ultra Sensitive Pregnancy Midstream 1-Test
Isletest GAD ELISA
Isletest IAA ELISA
Isletest ICA ELISA
NutriDetect 90G B ELISA