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Leishmaniasis IgG/IgM Rapid Test (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref LEI-4021/LEI-4022
Identity
- Trade Name
- Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- LEI-4021/LEI-4022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646LEI001GXV6 EUDAMED
- Basic UDI-DI
- B-697424646LEI001GXV6 EUDAMED
- EMDN Code
- W0105090499 PARASITES - RT & POC - OTHER EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma 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
Leishmaniasis IgG/IgM Rapid Test (Whole Blood +2 more) by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models
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-697424646LEI001GXV6 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- UnicareQ GmbH DE-AR-000051497
Sources (1)
- EUDAMED 5c480233-ebf2-4773-bf9f-522d8e415585 61 fields · synced Oct 6, 2026