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Mercodia Diabetes Antigen Control (Low, High) / Human
EUDAMEDClass IVD General (EU MDR)
Ref 10-1164-01
by Mercodia AB
Identity
- Trade Name
- Mercodia Diabetes Antigen Control (Low, High) / Human EUDAMED
- Device Name
- Mercodia Diabetes Antigen Control (Low, High) / Human EUDAMED
- Model / Reference
- 10-1164-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350108630160 EUDAMED
- Basic UDI-DI
- B-07350108630160 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Mercodia Diabetes Antigen Control (Low, High) / Human by Mercodia Ab — Class IVD General — 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-07350108630160 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Mercodia AB
- EUDAMED SRN
- SE-MF-000005175
Sources (1)
- EUDAMED fb601beb-0aa4-4824-9ce5-13277b97c1c5 61 fields · synced Jun 18, 2026