Identity
- Trade Name
- OPERAČNÍ PLÁŠŠ STANDARD XL EUDAMED
- Device Name
- Sterile Surgical Gowns EUDAMED
- Model / Reference
- MF-30110/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974531730733 EUDAMED
- Basic UDI-DI
- 697453173001KB EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Operační Plášš Standard Xl by Compass Surgical Innovations (Taizhou) Co., Ltd. — 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 | 697453173001KB | Class I | Active |
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Manufacturer
- Manufacturer
- Compass Surgical Innovations (Taizhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020691
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a30f6e0a-8a16-4b61-8a9d-d1478a73efe5 61 fields · synced Aug 2, 2026