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RapidFor™ Chlamydia + Gonorrhea Test Kit
EUDAMEDClass C (EU MDR)
Ref VMD109Model VMD109STS
Identity
- Trade Name
- RapidFor™ Chlamydia + Gonorrhea Test Kit EUDAMED
- Device Name
- Chlamydia + Gonorrhea Test Kit EUDAMED
- Model / Reference
- VMD109STS EUDAMEDVMD109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548259172 EUDAMED
- Basic UDI-DI
- 868354825VMD109STSQF EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class C 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
RapidFor™ Chlamydia + Gonorrhea Test Kit by Vitrosens Biotechnology Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 868354825VMD109STSQF | Class C | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 83743f21-ee57-47c7-af9d-8164ebe5599e 61 fields · synced Jul 12, 2026