Identity
- Trade Name
- Souprava ochranná EUDAMED
- Device Name
- PANEP STERISET EUDAMED
- Model / Reference
- 21552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592323009492 EUDAMED
- Basic UDI-DI
- 8592323PANEPSTERISETBQ EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- A set of medical devices and ancillary supplies intended, after sterilization, for the safe performance of minor outpatient procedures as well as complex surgical operations. The sets constitute a comprehensive system and, owing to their optimized composition, provide maximum utility value. They contain components designed for covering and protecting the surgical field, equipping the operating room, protecting medical personnel and the patient, agents for disinfection of the surgical site, materials for drying the surgical wound and its subsequent dressing, as well as additional items defined by the end user to ensure the safe execution of the surgical procedure. The sets are intended for single use and are supplied sterile. The most critical component is classified in risk class Is. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Souprava ochranná by PANEP s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8592323PANEPSTERISETBQ | Class I | Active |
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Manufacturer
- Manufacturer
- PANEP s.r.o.
- EUDAMED SRN
- CZ-PR-000032922
Sources (1)
- EUDAMED 73f2b897-2bf1-4731-a38d-07fdac0850c8 61 fields · synced Jul 13, 2026