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Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT105AModel 50 tests/kitRef HWTS-RT105BModel 20 tests/kitRef HWTS-RT105CModel 48 tests/kit
Identity
- Trade Name
- Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) EUDAMED
- Device Name
- Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-RT105A EUDAMED20 tests/kit EUDAMEDHWTS-RT105B EUDAMED48 tests/kit EUDAMEDHWTS-RT105C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-000012807042208NJ EUDAMEDD-00001280704210BNX EUDAMEDD-000012807042309NR EUDAMED
- Basic UDI-DI
- B-000012807042208NJ EUDAMEDB-00001280704210BNX EUDAMEDB-000012807042309NR EUDAMED
- EMDN Code
- W0105010799 MYCOBACTERIA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…
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-000012807042208NJ | Class IVD General | 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 (3)
- EUDAMED c0864145-d777-4f61-ac2a-4e2d910f6d19 61 fields · synced Jul 29, 2026
- EUDAMED e199f69a-2768-4188-abcd-ad206dfd8bf5 61 fields · synced May 18, 2026
- EUDAMED 4f097525-d675-4b66-8d10-33f8c42deaba 61 fields · synced May 18, 2026