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Vaginal/Endocervical Specimen Collection Tube
EUDAMEDClass A (EU MDR)
Ref STTY0201Ref STTY0401
Identity
- Trade Name
- Vaginal/Endocervical Specimen Collection Tube EUDAMED
- Device Name
- Vaginal/Endocervical Specimen Collection Tube EUDAMED
- Model / Reference
- STTY0201 EUDAMEDSTTY0401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980529 EUDAMED06974478980543 EUDAMED
- Basic UDI-DI
- 697447898STTY02015C EUDAMED697447898STTY04015N EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - 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
No
EUDAMED
New Device
No
EUDAMED
Vaginal/Endocervical Specimen 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 | 697447898STTY02015C | 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 (2)
- EUDAMED ddf026d1-1365-44a2-b058-d136963d40bf 61 fields · synced Jul 21, 2026
- EUDAMED 029aa154-bf20-4cf9-b76b-90b087a8d8b7 61 fields · synced May 18, 2026