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NX-Jr Genomic DNA Kit A
EUDAMEDClass A (EU MDR)
Ref VR131Model JGD061Ref JGD062Ref VD132Ref JUE061Ref FF131Ref JUE062
Identity
- Device Name
- NX-Jr Genomic DNA Kit A EUDAMED
- Model / Reference
- JGD061 EUDAMEDVR131 EUDAMEDJGD062 EUDAMEDVD132 EUDAMEDJUE061 EUDAMEDFF131 EUDAMEDJUE062 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800174502094 EUDAMED08800174503640 EUDAMED08800174502049 EUDAMED08800174503602 EUDAMED08800174501905 EUDAMED08800174503619 EUDAMED
- Basic UDI-DI
- 88001745-JR-R-5N EUDAMED
- Direct Marketing DI
- 08800174502094 EUDAMED08800174503640 EUDAMED08800174502049 EUDAMED08800174503602 EUDAMED08800174501905 EUDAMED08800174503619 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
NX-Jr Genomic DNA Kit A by Genolution. Inc. — Class A — IVDR — listed in EUDAMED — 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 | 88001745-JR-R-5N | Class A | Active |
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Manufacturer
- Manufacturer
- Genolution Inc.
- EUDAMED SRN
- KR-MF-000010391
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (6)
- EUDAMED 7a2166a4-28be-4cd7-ae47-62d4e4a4a6bc 61 fields · synced Jul 21, 2026
- EUDAMED 23cd4ac9-3ee9-4098-ae36-122af8f42bf9 61 fields · synced May 17, 2026
- EUDAMED 1180139f-88a2-42f6-937e-eb6a540c1287 61 fields · synced May 18, 2026
- EUDAMED cd18ad65-ee14-4f5f-88bc-7194c84be89c 61 fields · synced May 18, 2026
- EUDAMED 4ad73ac7-71a0-4489-b505-72aa9ab4e5a5 61 fields · synced May 18, 2026
- EUDAMED 5180f84c-e96f-4568-bb53-7d489c7aabaa 61 fields · synced May 18, 2026