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Vaginal/Endocervical Specimen Collection kit
EUDAMEDClass A (EU MDR)
Ref STTY03Ref STTY02Ref STTY04Ref STTY01
Identity
- Trade Name
- Vaginal/Endocervical Specimen Collection kit EUDAMED
- Device Name
- Vaginal/Endocervical Specimen Collection kit EUDAMED
- Model / Reference
- STTY03 EUDAMEDSTTY02 EUDAMEDSTTY04 EUDAMEDSTTY01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974478980574 EUDAMED06974478980567 EUDAMED06974478980581 EUDAMED06974478980550 EUDAMED
- Basic UDI-DI
- 697447898STTY03BX EUDAMED697447898STTY02BV EUDAMED697447898STTY04BZ EUDAMED697447898STTY01BT 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 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 | 697447898STTY03BX | 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 (4)
- EUDAMED 83ffdbf8-e8bd-496f-8520-f2cc3630691d 61 fields · synced Sep 18, 2026
- EUDAMED 11856330-89d1-4f38-808c-b39dfa6c256b 61 fields · synced May 11, 2026
- EUDAMED 748475f1-2edf-4beb-a195-525c3de9acf8 61 fields · synced May 17, 2026
- EUDAMED 6d229d61-cfa0-4ea4-9c98-5f8455c395e1 61 fields · synced May 17, 2026