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Oral Fluid Collection Tube
EUDAMEDClass A (EU MDR)
Ref STGJ0201Ref STGJ0301Ref STGJ0401
Identity
- Trade Name
- Oral Fluid Collection Tube EUDAMED
- Device Name
- Oral Fluid Collection Tube EUDAMED
- Model / Reference
- STGJ0201 EUDAMEDSTGJ0301 EUDAMEDSTGJ0401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980444 EUDAMED06974478980451 EUDAMED06974478980468 EUDAMED
- Basic UDI-DI
- 697447898STGJ0201ST EUDAMED697447898STGJ0301SY EUDAMED697447898STGJ0401T5 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES 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
No
EUDAMED
New Device
No
EUDAMED
Oral Fluid Collection Tube by Suzhou Shengtian 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 | 697447898STGJ0201ST | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Shengtian Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009632
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (3)
- EUDAMED 1596202a-c754-44ad-b085-56bb81184847 61 fields · synced Sep 17, 2026
- EUDAMED 4be7ad34-5f0f-413e-9ab2-138b847397fb 61 fields · synced May 16, 2026
- EUDAMED e9b62d64-a7f3-47d0-a9d2-fefdb9c687ff 61 fields · synced May 16, 2026