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sterile vaginal speculums for single use
EUDAMEDClass I (EU MDR)
Ref KVM005Model Middle Screw Type
Identity
- Device Name
- sterile vaginal speculums for single use EUDAMED
- Model / Reference
- Middle Screw Type EUDAMEDKVM005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950921000570 EUDAMED
- Basic UDI-DI
- 69509210ZLX67 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 speculums for single use by Taizhou Kangjian Medical Equipments 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 | 69509210ZLX67 | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Kangjian Medical Equipments Co., Ltd.
- EUDAMED SRN
- CN-MF-000011397
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 42e60e71-1f02-417e-8a23-d121a072fd39 61 fields · synced Jun 18, 2026