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EUDAMED last updated this device on Feb 21, 2024
B-00020221295153EXEL SRGCL BLADE,S-S, SIZE:22 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Exelint International, Co.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0002022129515329515US-MF-00003739610000357369-PA-NoMa-USANo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.(01)00020221295153
5 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 Netherlands; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Mar 26, 2021 | May 27, 2024 |
| France | Jan 1, 2025 | Still on market |
| Italy | Jan 1, 2025 | Still on market |
| Belgium | Mar 26, 2021 | May 27, 2024 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
V010302BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSESPrimary 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 →B-00020221295047On the marketEXEL SRGCL BLADE,S-S, SIZE:15B-00020221295085On the marketEXEL SRGCL BLADE,S-S, SIZE:20B-00020221295122On the marketEXEL SuperJect Dental Needle, 27G Long20221DNTNDL2657GOn the marketEXEL SuperJect Dental Needle, 27G Short20221DNTNDL2657GOn the marketEXEL SuperJect Dental Needle, 30G Long20221DNTNDL2657GOn the marketNo certificate specifically references this device's Basic UDI-DI.