- Role
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- Date of registration
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EUDAMED last updated this device on Apr 27, 2026
84357608INSGUIA5KBROCA LARGA Ø2,5X230MM NUMERADA ANCLAJE RAPIDO EXTRA-DURA XXXXXXX-EA (REF. SMITH POR DEFINIR) CE Clase I is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Ivalmed S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08435760802014IV703-04ES-MF-000000634Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →(01)08435760802014
The 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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Apr 27, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
L0399GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHERPrimary 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 →Certificate health across this manufacturer's portfolio.
ES26/00000408IssuedNotified 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 →84357608INSPERFORACION7MOn the marketBROCA LARGA 4X325MM ANCLAJE RAPIDO
5460100 CE Clase I84357608INSGUIA5KOn the marketBROCA LARGA Ø2,5X230MM NUMERADA ANCLAJE RAPIDO
XXXXXXX-EA
(REF. SMITH POR DEFINIR) CE Clase I84357608INSPERFORACION7MOn the marketBROCA LARGO 60 MM ANCLAJE CON REBAJE84357608INSPERFORACION7MOn the marketBROCA LARGO 60 MM CON TOPE ANCLAJE CON REBAJE84357608INSPERFORACION7MOn the marketBROCA LARGO 80 MM ANCLAJE CON REBAJE84357608INSPERFORACION7MOn the market