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Immunoglobulin M Kit
EUDAMEDClass IVD General (EU MDR)
Ref B29206Model Immunoglobulin M Kit 60mLRef B35205Model Immunoglobulin M Kit 50mLRef B28205Model Immunoglobulin M Kit 100mLRef B21206Model Immunoglobulin M 39 mL
Identity
- Trade Name
- Immunoglobulin M Kit EUDAMEDImmunoglobulin M EUDAMED
- Device Name
- Immunoglobulin M Kit EUDAMEDImmunoglobulin M EUDAMED
- Model / Reference
- Immunoglobulin M Kit 60mL EUDAMEDB29206 EUDAMEDImmunoglobulin M Kit 50mL EUDAMEDB35205 EUDAMEDImmunoglobulin M Kit 100mL EUDAMEDB28205 EUDAMEDImmunoglobulin M 39 mL EUDAMEDB21206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615138 EUDAMED08683555617453 EUDAMED08683555619013 EUDAMED08683555610676 EUDAMED
- Basic UDI-DI
- B-08683555615138 EUDAMEDB-08683555617453 EUDAMEDB-08683555619013 EUDAMEDB-08683555610676 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
Immunoglobulin M 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-08683555615138 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (4)
- EUDAMED f558261b-7a9f-48dd-b76f-3468764d2906 61 fields · synced Oct 6, 2026
- EUDAMED 4d033378-4d13-4b1a-83ae-962f604b7b1c 61 fields · synced May 18, 2026
- EUDAMED 2fadfa0a-8302-4682-b79e-153f012b310a 61 fields · synced May 19, 2026
- EUDAMED c2ffb698-721f-4651-b8be-e35d6e9a21fb 61 fields · synced May 19, 2026