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Oral Fluid Collection Kit
EUDAMEDClass A (EU MDR)
Ref STGJ02Ref STGJ03Ref STGJ04
Identity
- Trade Name
- Oral Fluid Collection Kit EUDAMED
- Device Name
- Oral Fluid Collection Kit EUDAMED
- Model / Reference
- STGJ02 EUDAMEDSTGJ03 EUDAMEDSTGJ04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980482 EUDAMED06974478980499 EUDAMED06974478980505 EUDAMED
- Basic UDI-DI
- 697447898STGJ026P EUDAMED697447898STGJ036R EUDAMED697447898STGJ046T 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 Kit 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 | 697447898STGJ026P | 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 dc8a8b0c-b67d-4dd2-a53a-6541fa3f5ebc 61 fields · synced Jul 29, 2026
- EUDAMED 4594a3c0-3e11-4228-8351-e090a46d1b2b 61 fields · synced May 17, 2026
- EUDAMED 028abd9c-5f4b-4918-a52e-f487a0f34881 61 fields · synced May 18, 2026