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Sterile Vaginal Speculum For Single Use
EUDAMEDClass I (EU MDR)
Ref VS0055Model SF-CK001，SF-CK002，SF-CK003，SF-CK004，SF-CK005，
Identity
- Trade Name
- Sterile Vaginal Speculum For Single Use EUDAMED
- Model / Reference
- SF-CK001，SF-CK002，SF-CK003，SF-CK004，SF-CK005， EUDAMEDVS0055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970097891642 EUDAMED
- Basic UDI-DI
- 697009789SVS001WG EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Vaginal Speculum For Single Use by Changzhou Shunfeng Plastic Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697009789SVS001WG | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Shunfeng Plastic Co., Ltd.
- EUDAMED SRN
- CN-MF-000014926
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b63d0766-47d4-4a73-8acb-2be9d84c95ec 61 fields · synced Jun 18, 2026