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Agamatrix Jazz Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 800003712
Identity
- Trade Name
- Agamatrix Jazz Test Strips EUDAMED
- Device Name
- Agamatrix Jazz Test Strips 50ct EUDAMED
- Model / Reference
- 800003712 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-800003712JG EUDAMED
- Basic UDI-DI
- B-800003712JG EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
No
EUDAMED
Agamatrix Jazz Test Strips 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-800003712JG | 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 5c5dd94b-cbf4-4a1e-af40-3e3465d978b8 61 fields · synced Jun 19, 2026