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Olerup QTYPE 11
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 201.701-10Model Olerup QTYPE 11Ref 201.701-03
by CareDx AB
Identity
- Device Name
- Olerup QTYPE 11 EUDAMED
- Model / Reference
- Olerup QTYPE 11 EUDAMED201.701-10 EUDAMED201.701-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340035525004 EUDAMED07340035525011 EUDAMED
- Basic UDI-DI
- B-07340035525004 EUDAMEDB-07340035525011 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Olerup QTYPE 11 by CareDx AB — Class IVD Annex II List B — 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-07340035525004 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (2)
- EUDAMED 4ac92b8e-6791-4154-9b2d-c5b7c31b962e 61 fields · synced Sep 17, 2026
- EUDAMED 937cfc18-6d42-4f59-90fe-4dbf899649f7 61 fields · synced May 18, 2026