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RAA Nucleic Acid Amplication Kit
EUDAMEDClass A (EU MDR)
Ref B00000A-96Ref B00000A
Identity
- Device Name
- RAA Nucleic Acid Amplication Kit EUDAMED
- Model / Reference
- B00000A-96 EUDAMEDB00000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440341 EUDAMED06975102440334 EUDAMED
- Basic UDI-DI
- 697510244B00000ANL EUDAMED
- Direct Marketing DI
- 06975102440341 EUDAMED06975102440334 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 | 697510244B00000ANL | 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 613ab954-edf3-4512-b3c7-06e3cd1c7c74 61 fields · synced Jul 30, 2026
- EUDAMED fa126105-b51f-427b-8dae-871ef45675dd 61 fields · synced May 18, 2026