X-ONE Trocar Ottico
by MEDI-LINE S.r.l. Italy EUDAMED
Ref 300-v3Model X-ONE Trocar Ottico EMDN K01010103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0003220524 | Date26 Nov 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ000322 Issued
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Dec 2022
- Expires
- 27 Dec 2027
- CSQ0003220524 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 26 Nov 2024
- Expires
- 27 Dec 2027
- Reason
- Add device or group
Specification
- Device Name
- X-ONE Trocar Ottico 3mm cannula Corta
- Model / Reference
- X-ONE Trocar Ottico, 300-v3
- Primary DI / UDI-DI
- 48055112881634
- Basic UDI-DI
- 805511288K01010103M2
- EMDN Code
- K01010103 Optical trocar, single-use
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000019935
From the manufacturer
Manufacturer's product page: X-ONE Trocar ottico e Trocar senza lama
Other devices from MEDI-LINE S.r.l.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 9f52acea-06d4-4aa7-a7eb-adc3b2d6c820