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Diagnostic Kit for Ureaplasma Urealyticum DNA (PCR-Fluorescence Probing)
EUDAMEDClass IVD General (EU MDR)
Ref DA0083Model Large package, 20 tests/kitRef DA0082Model Single tube, 20 tests/kitRef DA0081
Identity
- Device Name
- Diagnostic Kit for Ureaplasma Urealyticum DNA (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Large package, 20 tests/kit EUDAMEDDA0083 EUDAMEDSingle tube, 20 tests/kit EUDAMEDDA0082 EUDAMEDDA0081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103000830 EUDAMED06928103000823 EUDAMED06928103000816 EUDAMED
- Basic UDI-DI
- B-06928103000830 EUDAMEDB-06928103000823 EUDAMEDB-06928103000816 EUDAMED
- EMDN Code
- W0105010803 MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS 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
Yes
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
Diagnostic Kit for Ureaplasma Urealyticum DNA (PCR-Fluorescence Probing) by Daan Gene Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06928103000830 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 2424c6fd-d94f-4dca-9ce7-4bd6d93c2262 61 fields · synced Jul 25, 2026
- EUDAMED 4f8f13ac-6fa4-4462-9318-18ab0c1c2f2e 61 fields · synced May 17, 2026
- EUDAMED 137a6cad-1a3a-4387-8e3a-06bd4b408a3c 61 fields · synced May 19, 2026