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XL t(8 +1 more model
EUDAMEDClass C (EU MDR)
Ref D-5125-100-TCRef D-5110-100-OG
Identity
- Trade Name
- XL t(8;14) MYC/IGH DF 8cen EUDAMEDXL t(8;14) MYC/IGH DF EUDAMED
- Device Name
- XL t(8;14) MYC/IGH DF 8cen EUDAMEDXL t(8;14) MYC/IGH DF EUDAMED
- Model / Reference
- D-5125-100-TC EUDAMEDD-5110-100-OG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251315812611 EUDAMED04251315812468 EUDAMED
- Basic UDI-DI
- 42513158D-5125IVDK2 EUDAMED42513158D-5110IVDHL EUDAMED
- EMDN Code
- W01060209 T (8;14) EUDAMED
- Models / Variants
- XL t(8 EUDAMED14) MYC/IGH DF 8cen 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
Meet XL t(8;14) MYC/IGH DF 8cen, a cutting-edge medical device designed for precise microscopic analysis. This innovative device offers unparalleled accuracy and reliability in detecting microorganisms, making it an essential tool for various medical applications. With its advanced technology and robust design, XL t(8;14) MYC/IGH DF 8cen is poised to revolutionize the field of medicine.
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-5125IVDK2 | Class C | Active |
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Manufacturer
- Manufacturer
- MetaSystems Probes GmbH
- EUDAMED SRN
- DE-MF-000006315
Sources (2)
- EUDAMED 6d028293-ce1b-4011-92aa-c867c19c1cdf 61 fields · synced Sep 30, 2026
- EUDAMED 5280d626-d690-4716-9244-125b3935dee2 61 fields · synced May 19, 2026