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RapidFor™ Ovulation LH Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VMD61SModel VMD61S50Ref VMD61MModel VMD61M01Ref VMD61CModel VMD61C25
Identity
- Trade Name
- RapidFor™ Ovulation LH Test Kit EUDAMED
- Device Name
- Ovulation LH Test Kit EUDAMED
- Model / Reference
- VMD61S50 EUDAMEDVMD61S EUDAMEDVMD61M01 EUDAMEDVMD61M EUDAMEDVMD61C25 EUDAMEDVMD61C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595033739 EUDAMED08684595033722 EUDAMED08683347941674 EUDAMED
- Basic UDI-DI
- B-08684595033739 EUDAMEDB-08684595033722 EUDAMEDB-08683347941674 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
RapidFor™ Ovulation LH Test Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08684595033739 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (3)
- EUDAMED 0d04f134-aba6-4498-9cbf-a4593327718a 61 fields · synced Jul 13, 2026
- EUDAMED 581f61ce-46ab-4078-9995-d14d83920b25 61 fields · synced May 17, 2026
- EUDAMED 0c4bb12d-1702-4e8c-a391-cbed7812b892 61 fields · synced May 18, 2026