Identity
- Trade Name
- XL t(6;11) AFDN/KMT2A DF EUDAMED
- Device Name
- XL t(6;11) AFDN/KMT2A DF EUDAMED
- Model / Reference
- D-5132-100-OG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251315812673 EUDAMED
- Basic UDI-DI
- 42513158D-5132IVDJQ EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
- Models / Variants
- XL t(6 EUDAMED11) AFDN/KMT2A DF EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
XL t(6 +1 more model by Metasystems Probes Gmbh — Class C — IVDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 42513158D-5132IVDJQ | Class C | Active |
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Manufacturer
- Manufacturer
- MetaSystems Probes GmbH
- EUDAMED SRN
- DE-MF-000006315
Sources (1)
- EUDAMED a7e2bfd6-3d92-4839-9493-543294a07bb5 61 fields · synced Jul 17, 2026