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EUDAMED last updated this device on Jun 26, 2026
184350167bpacks01FMBundled Procedure Pack is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Servicio Integral Hospitalario, S.L.U.. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08435016708343Q4005811/141 packaging level registered — each level carries its own UDI-DI.
08435016708343× 1 unitBase unit18435016708340× 6 units(01)08435016708343
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q021113OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE5 warnings recorded — scroll inside the panel to see all entries.
Do not use any bundled item if their original packaging is open or damaged.
Do not use any bundled item after the expiry date stated on their original packaging.
This custom pack contains instructions of use included in the packaging. Dispose of all products contained in the pack, following the hospital practice once the surgical procedure is completed.
The outer packaging only provides a container for these bundled items. It is imperative that this outer packaging is completely removed and the packaging of all the bundled items enclosed within are opened outside of the sterile field.
ES-PR-000011724The 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.
2024 SR 0023IssuedNotified 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.
View in glossary →184350167bpacks01FMOn the marketBundled Procedure Pack184350167bpacks01FMOn the marketBundled Procedure Pack184350167bpacks01FMOn the marketBundled Procedure Pack184350167bpacks02FPOn the marketBundled Procedure Pack184350167bpacks01FMOn the marketBundled Procedure Pack184350167bpacks01FMOn the marketNo certificate specifically references this device's Basic UDI-DI.