← Back to catalogue
Extended Spectrum Beta-Lactamases (ESBLs) Producing Bacteria Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref QD-0225-02
Identity
- Trade Name
- Extended Spectrum Beta-Lactamases (ESBLs) Producing Bacteria Real Time PCR Kit EUDAMED
- Device Name
- Extended Spectrum Beta-Lactamases (ESBLs) Producing Bacteria Real Time PCR Kit EUDAMED
- Model / Reference
- QD-0225-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229206 EUDAMED
- Basic UDI-DI
- B-06971042229206 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Extended Spectrum Beta-Lactamases (ESBLs) Producing Bacteria Real Time PCR Kit by Shanghai Zj Bio-Tech 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-06971042229206 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 73dedc9f-dbba-4887-bb7d-9a5efe867b90 61 fields · synced Aug 2, 2026