- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 3, 2026
B-00850082432172Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Affimedix, Inc.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000053178(01)00850082432172
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Belgium; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Jun 15, 2016 | Jun 3, 2026 |
| Germany | Jun 15, 2016 | Jun 3, 2026 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00850082432172Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-008500824321721156-VDCUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050299SPECIFIC CONTROLS (CC) - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-00850082432004On the marketTestNOW® Testosterone Quantitative TestB-00850082432097On the marketVHC Vitamin D TestB-00850082432066On the marketVitamin D Control – CrinoCheck® Vitamin DB-00850082432165On the marketVitamin D Control – OnSight™ Vitamin D Quantitative TestB-00850082432189On the marketVitamin D Control – Rapi-D™ Quantitative Vitamin D TestB-00850082432158On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.