Sterile Vaginal Speculums for Single Use
by Taizhou Kangjian Medical Equipments Co., Ltd. 14 variants
Ref KVSFKS-01LModel French 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 | Number69509210FKS2N 06950921001362 | Date24 May 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- Withdrawn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
- French Type, KVSFKS-01L
- Primary DI / UDI-DI
- 06950921001362
- Basic UDI-DI
- 69509210FKS2N
- 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