Identity
- Trade Name
- OPER FILM PROTECT CHG 10 x 12 EUDAMED
- Device Name
- I.V. transparent dressing reinforced with clorhexidine gluconate EUDAMED
- Model / Reference
- 0034003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097959100 EUDAMED
- Basic UDI-DI
- B-08428097959100 EUDAMED
- EMDN Code
- M04040602 POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
OPER FILM PROTECT CHG 10 x 12 by Iberhospitex, S.A. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08428097959100 | Class III | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED 6816ec78-5b17-4776-b99e-1b22be713896 61 fields · synced Jun 18, 2026