Identity
- Device Name
- RT-RAA Nucleic Acid Amplication Kit EUDAMED
- Model / Reference
- B00R00A-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440440 EUDAMED
- Basic UDI-DI
- 697510244B00R00AVT EUDAMED
- Direct Marketing DI
- 06975102440440 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 by Jiangsu Qitian Gene biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697510244B00R00AVT | 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 (1)
- EUDAMED 33a5a4c6-2b6a-4bf9-a71d-05c22602c774 61 fields · synced Jun 19, 2026