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TGuide S16 Nucleic Acid Extractor
EUDAMEDClass A (EU MDR)
Ref OSE-S16-AMModel TGuide S16
Identity
- Trade Name
- TGuide S16 Nucleic Acid Extractor EUDAMED
- Device Name
- TGuide S16 Nucleic Acid Extractor EUDAMED
- Model / Reference
- TGuide S16 EUDAMEDOSE-S16-AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489970028 EUDAMED
- Basic UDI-DI
- 697548997OSES168A EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
TGuide S16 Nucleic Acid Extractor 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 | 697548997OSES168A | Class A | Active |
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Manufacturer
- Manufacturer
- Tiangen Biotech (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026594
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 95930fcb-2c64-4a06-9b57-ae04ebfc088c 61 fields · synced Jun 20, 2026