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Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref R061T050B0C1 Ref R061T016B0C1
Identity
- Device Name
- Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit EUDAMED
- Model / Reference
- R061T050B0C1 EUDAMEDR061T016B0C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895475594 EUDAMED06970895476072 EUDAMED06970895475570 EUDAMED
- Basic UDI-DI
- B-06970895475594 EUDAMEDB-06970895476072 EUDAMEDB-06970895475570 EUDAMED
- EMDN Code
- W0105010118 CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Mycoplasma Pneumoniae and Macrolides-Resistant Strain Nucleic Acid Test Kit by Jiangsu Mole Bioscience 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-06970895475594 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED c03f48f6-3bf5-4b47-b0e6-6337bab2dc57 61 fields · synced Jul 12, 2026
- EUDAMED 4e7792e5-a768-4d46-9125-394edf39204e 61 fields · synced May 18, 2026
- EUDAMED b8ec5bec-af8b-4797-a0c9-9d11729c8b25 61 fields · synced May 19, 2026