EU Manufacturer ๐Ÿ‡น๐Ÿ‡ผ Taiwan Active

Bionime Corporation

SRN: TW-MF-000008450 ยท Sec.2, Daqing St., South Dist. No. 100, 40242 Taichung City, Taiwan
Basic UDI-DIs
39
Total Devices
39
On Market
39
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
18

Basic Information

Address
Sec.2, Daqing St., South Dist. No. 100, 40242 Taichung City, Taiwan

Regulatory Overview

Regulation
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Eu Ivdd 36
Eu Mdd 2
Eu Mdr 1
Classification
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Eu Ivd Annex 2 List B 36
Eu Md Class 1 3
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Expired / Withdrawn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) HL 2110160-1 May 26, 2025

Market Presence

Devices from this manufacturer are available in 18 countries across Europe.

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

Device Portfolio

Name
Bionime Rightest GC300 Glucose Control Solution
Bionime Rightest GS100 Blood Glucose Test Strip
Bionime Rightest GS300 Blood Glucose Test Strip
Bionime Rightest Max Blood Glucose Test Strip
GE Blood Glucose Monitoring System GE100
GE Blood Glucose Monitoring System GE200
GE Blood Glucose Monitoring System GE200
Mylife Unio Cara Blood Glucose Monitoring System
RIGHTEST ALPHA Blood Glucose Monitoring System
RIGHTEST Alma Blood Glucose Monitoring System
RIGHTEST Blood Glucose Monitoring System GM260
RIGHTEST Blood Glucose Monitoring System GM280B
RIGHTEST Blood Glucose Monitoring System GM300
RIGHTEST Blood Glucose Monitoring System GM700
RIGHTEST Blood Glucose Monitoring System GM700 Pro 2
RIGHTEST Blood Glucose Monitoring System GM700S
RIGHTEST Blood Glucose Monitoring System GM700SB
RIGHTEST Blood Glucose Monitoring System GM720
RIGHTEST Brisa Blood Glucose Monitoring System
RIGHTEST Brisa Plus Blood Glucose Monitoring System
RIGHTEST Brisa Plus Blood Glucose Monitoring System
RIGHTEST ELSA Blood Glucose Monitoring System
RIGHTEST GM100 Blood Glucose Monitoring System
RIGHTEST GM110 Blood Glucose Monitoring System
RIGHTEST GT333 Blood Glucose Monitoring System
RIGHTEST Lancing Device
RIGHTEST Max Blood Glucose Monitoring System
RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System
RIGHTEST Max Plus Blood Glucose Monitoring System
RIGHTEST Sol Blood Glucose Monitoring System
RIGHTEST Sol Plus Blood Glucose Monitoring System
RIGHTEST Wiz Blood Glucose Monitoring System
RIGHTEST Wiz Plus Blood Glucose Monitoring System
Rightest Blood Glucose Meter GM700 Pro
Rightest Blood Glucose Monitoring System
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
mylife Unio Neva Blood Glucose Monitoring System