Vitalscientific
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000004722 FEI 3007662974
Vitalscientific is a medical device manufacturer based in France, with 511 devices listed in EUDAMED and FDA GUDID (EU Class B, IVD General and Class A) and 6 FDA recalls as of 13 Nov 2026.
- Devices
- 511
- Registrations
- EUDAMEDFDA
- FDA recalls
- 6
Registry facts
- Registries
- EUDAMED 336
- FDA GUDID 219
- Device classes
- EU Class B 295
- EU IVD General 22
- EU Class A 18
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN FR-MF-000004722
- FDA FEI 3007662974
- DUNS 267732378
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
What Vitalscientific makes
VitalScientific manufactures in vitro diagnostic (IVD) reagents, kits, and controls for clinical chemistry testing, including total cholesterol, uric acid, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lipase, calcium, and multiple analyte profiles. Their products are designed for spectrophotometric analysis and include bulk rinse solutions, calibrators, and serum controls for laboratory use.
The company’s portfolio is regulated under EU IVD General, Class A, and Class B classifications, with devices listed in the EUDAMED registry and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in France.
Catalogue
Search and filter all 511 devicesShowing 1-50 of 511
Company details
- EUDAMED SRN
- FR-MF-000004722
- FDA FEI number
- 3007662974
- DUNS number
- 267732378
- EU VAT number
- FR37 318365228
- EUDAMED status
- Active
- EUDAMED registered name
- VitalScientific
- EUDAMED abbreviated name
- VS
- Registered address
- 13, AUGUSTE MOTTIN, 61500, SEES, France
- Website
- https:/www.vitalscientific.com
- PRRC contact
- Valérie LAMBERT
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 2 Apr 2029
GMED SAS 0459 1 certificate
- 39658 Active
Quality management system EU IVDR
- Issued
- 6 Aug 2026
- Expires
- 2 Apr 2029
- Reason
- Other
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 18 Apr 2017 Z-2591-2018 Class II Terminated ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.
2015
- 22 Sep 2015 Z-0214-2016 Class II Terminated ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
- 22 Sep 2015 Z-0215-2016 Class II Terminated ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.
- 22 Sep 2015 Z-0216-2016 Class II Terminated ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
- 22 Sep 2015 Z-0217-2016 Class II Terminated ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
2014
- 11 Aug 2014 Z-0006-2015 Class III Terminated Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
Frequently asked questions
How many devices does VITALSCIENTIFIC have in the registry?
The registry currently lists 511 devices for VITALSCIENTIFIC. Devices recorded under merged duplicate company entries are counted once.
Which registries list VITALSCIENTIFIC's devices?
Among its 50 most recently registered devices, VITALSCIENTIFIC has devices listed in EUDAMED (18 devices) and FDA GUDID (33 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do VITALSCIENTIFIC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for VITALSCIENTIFIC's devices are IVDR Class B and IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for VITALSCIENTIFIC?
FDA recall records list 6 recalls initiated by VITALSCIENTIFIC, the most recent initiated on 18 Apr 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for VITALSCIENTIFIC?
EUDAMED lists 1 certificate for VITALSCIENTIFIC (quality management system) under IVDR. The most recent was issued on 6 Aug 2026.
What are the newest devices from VITALSCIENTIFIC in the registry?
The most recently registered devices listed for VITALSCIENTIFIC include CK-MB CONTROL, CRP LATEX, LDL CALIBRATOR KIT 55115 and HDL CALIBRATOR KIT 55119.