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RAA Nucleic Acid Amplication Kit(Test Strip Method)
EUDAMEDClass A (EU MDR)
Ref T00001ARef T00001A-96
Identity
- Device Name
- RAA Nucleic Acid Amplication Kit(Test Strip Method) EUDAMED
- Model / Reference
- T00001A EUDAMEDT00001A-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440389 EUDAMED06975102440419 EUDAMED
- Basic UDI-DI
- 697510244T00001AY9 EUDAMED
- Direct Marketing DI
- 06975102440389 EUDAMED06975102440419 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
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 | 697510244T00001AY9 | 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 fcf97bc0-5296-4887-8f1f-758563b49906 61 fields · synced Jul 20, 2026
- EUDAMED 2a43fa6f-a334-45bb-b8a0-523f4bd4211e 61 fields · synced May 18, 2026