Identity
- Trade Name
- OPER FILM PROTECT IV 8,5 X 10,5 CM EUDAMED
- Device Name
- IV Transparent dressing reinforced EUDAMED
- Model / Reference
- 0037503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097945905 EUDAMED
- Basic UDI-DI
- 8428097OFPIV73 EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Oper Film Protect Iv 8, 5 X 10, 5 Cm by Iberhospitex, S.A. — 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 | 8428097OFPIV73 | Class I | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED d84ab88d-e4e7-4240-956f-0f02c760158d 61 fields · synced Jul 28, 2026