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SSP KIR Genotyping
EUDAMEDClass IVD General (EU MDR)
Ref 104.101-12uModel Olerup SSP
by CareDx AB
Identity
- Device Name
- SSP KIR Genotyping EUDAMED
- Model / Reference
- Olerup SSP EUDAMED104.101-12u EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340035508069 EUDAMED
- Basic UDI-DI
- B-07340035508069 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Sweden 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
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
SSP KIR Genotyping by CareDx AB — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-07340035508069 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (1)
- EUDAMED 61d6138c-2ce5-42b2-9ea1-729d78bb8ccb 61 fields · synced Jul 13, 2026