← Back to catalogue
Immunoglobulin E (IgE)
EUDAMEDClass IVD General (EU MDR)
Ref B22195Model Immunoglobulin E 60 mL
Identity
- Trade Name
- Immunoglobulin E (IgE) EUDAMED
- Device Name
- Immunoglobulin E EUDAMED
- Model / Reference
- Immunoglobulin E 60 mL EUDAMEDB22195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555612113 EUDAMED
- Basic UDI-DI
- B-08683555612113 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 E (IgE) 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-08683555612113 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (1)
- EUDAMED c470dd27-9d7b-4733-a595-6a253321e759 61 fields · synced Aug 2, 2026