Surgical drapes
by DINA – HITEX, spol. s r.o. EUDAMED
Active
Ref 301-198-SModel Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8591527000100ISPB | Date3 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2023-MDR/QS-044 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 10 Nov 2023
- Expires
- 10 Nov 2028
Specification
- Model / Reference
- Cardiovascular, ENT, General, Gynaecology, Incision, Laparoscopic, Mini-invasive, Multi-organ, Neurosurgery, Ophthalmology, Orthopaedic, Plastic, Stomatology, Thoracic, Urology, Vascular, Interventional radiology, EsySuit, Other, 301-198-S
- Primary DI / UDI-DI
- 08591527223864
- Basic UDI-DI
- 8591527000100ISPB
- EMDN Code
- T020102 Specialistic surgery drapes
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CZ-MF-000000312
Other devices from DINA – HITEX, spol. s r.o.
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