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IgM Kit
EUDAMEDClass IVD General (EU MDR)
Ref B30205Model IgM Kit 100mL Ref B27206Model IgM Kit 50 mLRef B27205Model IgM Kit 100mL
Identity
- Trade Name
- IgM Kit EUDAMED
- Device Name
- IgM Kit EUDAMED
- Model / Reference
- IgM Kit 100mL EUDAMEDB30205 EUDAMEDIgM Kit 50 mL EUDAMEDB27206 EUDAMEDB27205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555614414 EUDAMED08683555612922 EUDAMED08683555612915 EUDAMED
- Basic UDI-DI
- B-08683555614414 EUDAMEDB-08683555612922 EUDAMEDB-08683555612915 EUDAMED
- EMDN Code
- W0103080202 IGA, IGD, IGM, IGG, IGE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
IgM Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555614414 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (3)
- EUDAMED 1a4c0781-703d-4fc0-a76e-9870ef7c3abc 61 fields · synced Jul 9, 2026
- EUDAMED 9289dfb5-8250-4ab1-a2df-12ee69dc6df5 61 fields · synced May 17, 2026
- EUDAMED b3154638-32a0-4a61-ab4f-95c644d184aa 61 fields · synced May 19, 2026