Identity
- Trade Name
- JDBIOTECH EUDAMED
- Device Name
- JDBIOTECH Mycoplasma genitalium Antigen Rapid Test EUDAMED
- Model / Reference
- JTBAG EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69301021JTBAGG3E5 EUDAMED
- Basic UDI-DI
- B-69301021JTBAGG3E5 EUDAMED
- EMDN Code
- W0105900299 INFECTIOUS IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Jdbiotech by Jei Daniel (JD) Biotech Corp. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-69301021JTBAGG3E5 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jei Daniel (JD) Biotech Corp.
- EUDAMED SRN
- CN-MF-000039637
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 017ae359-9533-4bf9-9d3f-a0112c4b72c1 61 fields · synced Jul 13, 2026