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Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)
EUDAMEDClass B (EU MDR)
Ref BSJ09L1Model BSJ09S1, BSJ09M1, BSJ09L1Ref BSJ09M1
Identity
- Trade Name
- Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) EUDAMED
- Device Name
- Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) EUDAMED
- Model / Reference
- BSJ09S1, BSJ09M1, BSJ09L1 EUDAMEDBSJ09L1 EUDAMEDBSJ09M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227801 EUDAMED06973843227870 EUDAMED
- Basic UDI-DI
- 697384322BSJ09JS EUDAMED
- Direct Marketing DI
- 06973843227801 EUDAMED06973843227870 EUDAMED
- EMDN Code
- W010501080301 MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR) by Hangzhou Bioer Technology Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 697384322BSJ09JS | Class B | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 2be3ca7a-96b4-4dc3-a815-456d7eaf015a 61 fields · synced Jul 30, 2026
- EUDAMED 6964796d-0acc-4d69-a959-ba77dc2541f5 61 fields · synced May 18, 2026