← Back to catalogue
Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma)
EUDAMEDClass IVD General (EU MDR)
Ref HAV-3012
Identity
- Trade Name
- Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma) EUDAMED
- Device Name
- Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma) EUDAMED
- Model / Reference
- HAV-3012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646HAV003GWW7 EUDAMED
- Basic UDI-DI
- B-697424646HAV003GWW7 EUDAMED
- EMDN Code
- W0105090299 HEPATITIS VIRUSES - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
An IgM rapid test for detecting Hepatitis A Virus (HAV) infection, providing accurate and reliable results in a short amount of time. This device is designed to be simple and user-friendly, with a low cost and minimal maintenance requirements. It is suitable for general use by individuals who may not require specialized medical equipment.
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-697424646HAV003GWW7 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- UnicareQ GmbH DE-AR-000051497
Sources (1)
- EUDAMED c1f263d7-119b-451b-bec8-9ae8a57b09ac 61 fields · synced Jun 21, 2026