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Leptospira IgG/IgM Rapid Test Cassette (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref GCLEP(IgG/IgM)-402a
Identity
- Trade Name
- Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) EUDAMED
- Model / Reference
- GCLEP(IgG/IgM)-402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCLEP(IgG/IgM)-402aHG8L EUDAMEDD-GCLEP(IgG/IgM)-402aRF EUDAMED
- Basic UDI-DI
- B-GCLEP(IgG/IgM)-402aHG8L EUDAMEDB-GCLEP(IgG/IgM)-402aRF EUDAMED
- EMDN Code
- W0105011704 LEPTOSPIRA 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
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Leptospira IgG/IgM Rapid Test Cassette (Whole Blood +2 more) by Healgen Scientific Limited Liability Company — Class IVD General — IVDD — listed in EUDAMED…
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-GCLEP(IgG/IgM)-402aHG8L | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 2ce95b0e-a5ed-45b8-a1ff-2617095ab4a9 61 fields · synced Oct 7, 2026
- EUDAMED 6e686c46-d919-4eb8-b9be-1e0d4a03fab0 61 fields · synced Jun 18, 2026