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RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)
EUDAMEDClass A (EU MDR)
Ref F00R01A-96Ref F00R01A
Identity
- Device Name
- RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method) EUDAMED
- Model / Reference
- F00R01A-96 EUDAMEDF00R01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440426 EUDAMED06975102440372 EUDAMED
- Basic UDI-DI
- 697510244F00R01AY2 EUDAMED
- Direct Marketing DI
- 06975102440426 EUDAMED06975102440372 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(Fluorescent 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 | 697510244F00R01AY2 | 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 86c148b3-3db1-4d53-9c1f-7c030b354c3b 61 fields · synced Aug 2, 2026
- EUDAMED a8de0660-003b-4cb8-ac2a-d35405992856 61 fields · synced May 17, 2026