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Agamatrix Control Solution Normal
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 80003550Model 800003550
Identity
- Trade Name
- Agamatrix Control Solution Normal EUDAMED
- Device Name
- Agamatrix Control Solution Normal EUDAMED
- Model / Reference
- 800003550 EUDAMED80003550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00385540355002 EUDAMED
- Basic UDI-DI
- B-00385540355002 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS 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
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Agamatrix Control Solution Normal 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-00385540355002 | 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 6fc59396-9155-4e51-8b56-a81d814c603e 61 fields · synced Jul 11, 2026