- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Feb 26, 2025
B-07899330015265Kit for Keraring Implantation is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Mediphacos Industrias Médicas S/A. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
BR-MF-000015743(01)07899330015265
2 warnings recorded — scroll inside the panel to see all entries.
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 Portugal; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Romania | — | Still on market |
| Türkiye | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07899330015265Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-07899330015265OOF030UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
L1099MICROSURGERY 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 →No certificate specifically references this device's Basic UDI-DI.
B-07899330003521On the marketKeraring Surgical InstrumentsB-07899330003569On the marketKeraring Surgical InstrumentsB-07899330015357On the marketKit for Keraring ImplantationB-07899330003552On the marketKit for Keraring ImplantationB-07899330003538On the marketKit for Keraring ImplantationB-07899330005921On the marketCertificate health across this manufacturer's portfolio.
10000491237-PA-NoMA-BRAIssuedNotified 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 →