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HAV IgM Rapid Test Cassette (Serum/Plasma)
EUDAMEDClass IVD General (EU MDR)
Ref 1192 001Ref VT-HAVM-25Model HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta
Identity
- Trade Name
- HAV IgM Rapid Test Cassette (Serum/Plasma) EUDAMEDHAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta EUDAMED
- Device Name
- HAV IgM Rapid Test Cassette (Serum/Plasma) EUDAMEDHAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta EUDAMED
- Model / Reference
- 1192 001 EUDAMEDHAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta EUDAMEDVT-HAVM-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041043500 EUDAMED05944759080072 EUDAMED
- Basic UDI-DI
- B-62230041043500 EUDAMED5944759080VTHAVM25SPCB6JW EUDAMED
- Direct Marketing DI
- 05944759080072 EUDAMED
- EMDN Code
- W0105090299 HEPATITIS VIRUSES - RT & POC - OTHER EUDAMEDW01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
HAV IgM Rapid Test Cassette (Serum/Plasma) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-62230041043500 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-62230041043500 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 67e3ec87-390d-4ddf-a514-60abdaeb6254 61 fields · synced Oct 6, 2026
- EUDAMED fd284201-a699-43be-91e5-74aab2da8f67 61 fields · synced Jun 18, 2026