Identity
- Trade Name
- Incifilm® Incision drapes EUDAMED
- Device Name
- Incifilm® Incision drapes EUDAMED
- Model / Reference
- IN820850 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06222023803916 EUDAMED
- Basic UDI-DI
- 62220238Incifilm4Y EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
The Incifilm® Incision drapes are a medical device used for creating incisions in the human body. They are sterilized using advanced technology and come with various features such as sterile packaging, multiple components, and self-testing capabilities. The device is designed to meet specific regulatory requirements, ensuring patient safety.
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 | 62220238Incifilm4Y | Class I | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 15fc0dd6-f813-48c8-bec1-7d5e110ea1ad 61 fields · synced Aug 1, 2026