Identity
- Trade Name
- XL t(11;14) MYEOV/IGH DF EUDAMED
- Device Name
- XL t(11;14) MYEOV/IGH DF EUDAMED
- Model / Reference
- D-5111-100-OG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251315812475 EUDAMED
- Basic UDI-DI
- 42513158D-5111IVDHT EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
- Models / Variants
- XL t(11 EUDAMED14) MYEOV/IGH 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(11 +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-5111IVDHT | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MetaSystems Probes GmbH
- EUDAMED SRN
- DE-MF-000006315
Sources (1)
- EUDAMED 55f14f51-3478-40c0-9c8f-d145fd37aaee 61 fields · synced Jun 19, 2026