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Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)
EUDAMEDClass B (EU MDR)
Ref HWTS-OT149CModel HWTS-OT149A
Identity
- Trade Name
- Carbapenem Resistance Gene Detection Kit (Fluorescence PCR) EUDAMED
- Device Name
- Carbapenem Resistance Gene Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- HWTS-OT149A EUDAMEDHWTS-OT149C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849369663 EUDAMED
- Basic UDI-DI
- 697484936HWTS-OT149A5A EUDAMED
- EMDN Code
- W0104080606 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE EUDAMED
Classification
- Device Class
- Class B 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
Yes
EUDAMED
Carbapenem Resistance Gene Detection Kit (Fluorescence PCR) by Jiangsu Macro & Micro-Test Med-Tech 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 | 697484936HWTS-OT149A5A | Class B | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 13eadc80-0270-4a69-ad09-7ac6cefd3424 61 fields · synced Jun 19, 2026