EU Manufacturer
🇫🇷 France
Active
BIOSYNEX
SRN: FR-MF-000014073
·
BOULEVARD SÉBASTIEN BRANT 22, 67400 ILLKIRCH-GRAFFENSTADEN , France
Basic UDI-DIs
26
Total Devices
51
On Market
43
Off Market
8
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- BOULEVARD SÉBASTIEN BRANT 22, 67400 ILLKIRCH-GRAFFENSTADEN , France
- [email protected]
- Website
- biosynex.com
Regulatory Overview
Regulation
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Eu Ivdr
24
Eu Mdr
2
Classification
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Eu Ivd Class A
15
Eu Ivd Class C
9
Eu Md Class 1
2
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
🇧🇪 Belgium
🇫🇷 France
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BIOSYNEX AMPLIFLASH GBS | EU IVDR | Eu Ivd Class C | Off Market | 0 |
| BIOSYNEX AMPLIFLASH Malaria | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Bordetella | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Bordetella | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Bacteriology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Bacteriology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Bacteriology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Pretreatment | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Virology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Virology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Fecal Virology | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Leptospira | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Lysis | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| BIOSYNEX AMPLIQUICK Lysis | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX AMPLIQUICK Lysis | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX AMPLIQUICK Malaria | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Malaria | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BIOSYNEX AMPLIQUICK Sample Collection | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX AMPLIQUICK Sample Collection | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX AMPLIQUICK Sample Treatment | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX Blood Lysis | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOSYNEX IntimaSwab | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| BIOSYNEX Tsmart INR Professional | EU IVDR | Eu Ivd Class C | On Market | 0 |
| BORELLI | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| BORELLI | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| BORELLI | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| BSX READER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Biosynex Chambre d'inhalation 0-9 mois | EU MDR | Eu Md Class 1 | On Market | 0 |
| Biosynex Chambre d'inhalation 6 ans et plus | EU MDR | Eu Md Class 1 | On Market | 0 |
| Biosynex Chambre d'inhalation 9 mois-6 ans | EU MDR | Eu Md Class 1 | On Market | 0 |
| Labpad Evolution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEMOCERVICAL | EU MDR | Eu Md Class 1 | On Market | 0 |
| MYCETBLUE | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MYCETCOLOR | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| MYCETFLUO | EU IVDR | Eu Ivd Class A | Off Market | 0 |
| PARA-SELLES OPTIMA - BAILENGER A2 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| PARA-SELLES OPTIMA - IODESINE / BAILENGER A3 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| PARA-SELLES OPTIMA - Technique B | EU IVDR | Eu Ivd Class A | On Market | 0 |
| PARA-SELLES OPTIMA – IODESINE A1 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Procise Stool Collection Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Procise Stool Collection Kit for Laboratory Use | EU IVDR | Eu Ivd Class A | On Market | 0 |