Sterile Vaginal Speculums for Single Use
by Taizhou Kangjian Medical Equipments Co., Ltd. 14 variants
Ref KVSXK002Model Spanish Type
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69509210XKS5G 06950921001126 | Date24 Aug 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Spanish Type, KVSXK002
- Primary DI / UDI-DI
- 06950921001126
- Basic UDI-DI
- 69509210XKS5G
- EMDN Code
- U089006 Vaginal speculum, single-use
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000011397
- Authorised representative
- phoenix Medtech GmbH DE-AR-000007996
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Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No