Identity
- Trade Name
- TGuide S32 Magnetic Viral DNA/RNA Kit EUDAMED
- Device Name
- TGuide S32 Magnetic Viral DNA/RNA Kit EUDAMED
- Model / Reference
- CDP604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489971155 EUDAMED
- Basic UDI-DI
- 697548997CDP604TY 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
TGuide S32 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 | 697548997CDP604TY | Class A | Active |
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Manufacturer
- Manufacturer
- Tiangen Biotech (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026594
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 78247196-c006-4af1-9cf5-ef7c46df183e 61 fields · synced Jul 24, 2026