← Back to catalogue
V-Calm Lh Test De Ovulación
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref VCALMLH10Model Cassette
Identity
- Trade Name
- V-CALM LH TEST DE OVULACIÓN EUDAMED
- Device Name
- LH Ovulation Tests EUDAMED
- Model / Reference
- Cassette EUDAMEDVCALMLH10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134689 EUDAMED
- Basic UDI-DI
- B-06942468134689 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
V-Calm Lh Test De Ovulación by Core Technology Co., Ltd. — Class IVD devices for self-testing — 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-06942468134689 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Core Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023522
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 4d52ea63-38f3-4d62-9516-c22427168940 61 fields · synced Jun 18, 2026