← Back to catalogue
Magnetic Viral DNA/RNA Kit
EUDAMEDClass A (EU MDR)
Ref CDP438-T4AModel CDP438-01, CDP438-T3E, CDP438-T4ARef CDP438-01Ref CDP438-T3E
Identity
- Trade Name
- Magnetic Viral DNA/RNA Kit EUDAMED
- Device Name
- Magnetic Viral DNA/RNA Kit EUDAMED
- Model / Reference
- CDP438-01, CDP438-T3E, CDP438-T4A EUDAMEDCDP438-T4A EUDAMEDCDP438-01 EUDAMEDCDP438-T3E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489971148 EUDAMED06975489971124 EUDAMED06975489971131 EUDAMED
- Basic UDI-DI
- 697548997CDP438U7 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Magnetic Viral DNA/RNA Kit by Tiangen Biotech (Beijing) 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 | 697548997CDP438U7 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tiangen Biotech (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026594
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (3)
- EUDAMED 393f5198-b9d7-4a98-a052-f55fc1fe6c89 61 fields · synced Jul 30, 2026
- EUDAMED d629d29d-eddf-405c-b164-2d8c178ab9bd 61 fields · synced May 18, 2026
- EUDAMED b0d53565-d72a-49ab-9552-adaca3cbbac3 61 fields · synced May 18, 2026