Kratz-Barraquer Speculum Standard Wire, Lg
Ref D10-5050Model D10-5000-9019
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 | Number++G006OphthalSpeculumU8 +G006D10505001 | Date5 Dec 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- Withdrawn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
- Device Name
- Ophthalmic Speculums
- Model / Reference
- D10-5000-9019, D10-5050
- Primary DI / UDI-DI
- +G006D10505001
- Basic UDI-DI
- ++G006OphthalSpeculumU8
- EMDN Code
- L03140199 Spreaders and retractors for general surgery, reusable - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- PK-MF-000009615
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Daud Jee Mfg. Co
Properties
Other properties (12)
- Sterile: No
- Implantable: 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