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EUDAMED last updated this device on May 6, 2026
8428097OFPIV73OPER FILM PROTECT IV 8,5 X 10,5 CM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Iberhospitex, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0842809794590500375032 packaging levels registered — each level carries its own UDI-DI.
08428097945905× 1 unitBase unit08428097946223× 50 units08428097946032× 10 units(01)08428097945905
European Medical Device Nomenclature — the EU product classification assigned to this device.
M04010202POLYURETHANE FIXING DRESSINGS2 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jul 11, 2025 | Still on market |
ES-MF-000000160The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
2025 CR 0045SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
2024 PR 0030IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
ES22/00000630AmendedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
No certificate specifically references this device's Basic UDI-DI.
8428097OFPIV73On the marketOPER FILM PROTECT IV 7 x 8,5 cm8428097OFPIV73On the marketOPER FILM PROTECT IV 7 x 8,5 cm8428097OFPIV73On the marketOPER FIM PROTECT IV 11 X 14 CM8428097OFPIV73On the marketOPER TAPE 2,5 x 1000 cm8428097TAPE99On the marketOPER TAPE 10 x 1000 cm8428097TAPE99On the market