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Agamatrix Wavesense Jazz Wireless meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 8000-10409
Identity
- Trade Name
- Agamatrix Wavesense Jazz Wireless meter EUDAMED
- Device Name
- Agamatrix Wavesense Jazz Wireless meter EUDAMED
- Model / Reference
- 8000-10409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060181540028 EUDAMED
- Basic UDI-DI
- B-05060181540028 EUDAMED
- EMDN Code
- W0201060102,W020106019085 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Agamatrix Wavesense Jazz Wireless meter by Agamatrix, Inc. — Class IVD Annex II List B — 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-05060181540028 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- AgaMatrix, Inc.
- EUDAMED SRN
- US-MF-000039145
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2e7c1497-656d-481d-93da-30287f15ac12 61 fields · synced Jul 25, 2026