Pasante Probe Covers clinic pack
by Karex Industries Sdn. Bhd. Malaysia EUDAMED
Ref 8203KModel KX07 Unlubricated
EMDN Z11040185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-05032331016066 | Date16 Oct 2026 | StatusActive |
| European Union | CE/MDD | NumberB-05032331016066 | Date16 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Pasante Probe Covers clinic packPasante KX07 Non-Sterile, Unlubricated
- Device Name
- Non-sterile Natural Rubber Latex Protective Transducer Covers
- Model / Reference
- KX07 Unlubricated, 8203K
- Primary DI / UDI-DI
- 05032331016066
- Basic UDI-DI
- B-05032331016066, 9556564-NSPC-WH
- EMDN Code
- Z11040185 Ultrasound scanners - consumables
- Device Class
- Class IIa
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- MY-MF-000001247
- Authorised representative
- Advena Limited MT-AR-000000234
From the manufacturer
Manufacturer's product page: e-Brochure
Other devices from Karex Industries Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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
Sources (2)
- EUDAMED 05032331016066|B-05032331016066
- EUDAMED 05032331016066|9556564-NSPC-WH