← Back to catalogue
Luteinizing Hormone (LH) Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref G5402CVRef G5403CC
Identity
- Trade Name
- Luteinizing Hormone (LH) Test Kit EUDAMED
- Device Name
- Luteinizing Hormone (LH) Test Kit EUDAMED
- Model / Reference
- G5402CV EUDAMEDG5403CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739191 EUDAMED06979469761521 EUDAMED
- Basic UDI-DI
- B-06973315739191 EUDAMEDB-06979469761521 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Luteinizing Hormone (LH) Test Kit by Nanjing Vazyme Medical Technology Co., Ltd. — 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-06973315739191 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED b4fa3cf4-fce6-4f83-8e38-4b053d6bfcb9 61 fields · synced Oct 7, 2026
- EUDAMED a331fec1-1a3a-4951-aae6-48a0c4fe7e36 61 fields · synced Jun 20, 2026