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RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)
EUDAMEDClass A (EU MDR)
Ref T00R01A-96Ref T00R01A
Identity
- Device Name
- RT-RAA Nucleic Acid Amplication Kit(Test Strip Method) EUDAMED
- Model / Reference
- T00R01A-96 EUDAMEDT00R01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440402 EUDAMED06975102440396 EUDAMED
- Basic UDI-DI
- 697510244T00R01A7K EUDAMED
- Direct Marketing DI
- 06975102440402 EUDAMED06975102440396 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A 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
RT-RAA Nucleic Acid Amplication Kit(Test Strip Method) by Jiangsu Qitian Gene biotechnology Co., Ltd — Class A — 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 | 697510244T00R01A7K | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d59f9fc5-b488-4298-b142-f81fb849b3f2 61 fields · synced Jul 9, 2026
- EUDAMED 39365b5e-f1a8-461a-adab-cf8cf255d690 61 fields · synced May 18, 2026