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Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluore…
EUDAMEDClass C (EU MDR)
Ref BSJ02M1AModel BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1ARef BSJ02L1ARef BSJ02S1A
Identity
- Trade Name
- Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR) EUDAMED
- Device Name
- Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit EUDAMED
- Model / Reference
- BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A EUDAMEDBSJ02M1A EUDAMEDBSJ02L1A EUDAMEDBSJ02S1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227757 EUDAMED06973843227740 EUDAMED06973843227825 EUDAMED
- Basic UDI-DI
- 697384322BSJ02JC EUDAMED
- Direct Marketing DI
- 06973843227757 EUDAMED06973843227740 EUDAMED06973843227825 EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluore… by Hangzhou Bioer Technology Co., Ltd. — Class C — 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 | 697384322BSJ02JC | Class C | 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 (3)
- EUDAMED 684089e2-fda8-49f7-bd75-99a657b911dc 61 fields · synced Jul 9, 2026
- EUDAMED 2f34879e-70cf-4d78-9ee5-23eda6b50f35 61 fields · synced May 17, 2026
- EUDAMED 0a800826-bb18-4dd9-9a56-54c14c000c0e 61 fields · synced May 17, 2026