- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jul 7, 2026
B-08806387821489Q01010401 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by META BIOMED CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08806387821489-(01)08806387821489
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q01010401PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY1 warning recorded — scroll inside the panel to see all entries.
1. Should be use sterilized paper points 2. Do not use bent or broken points 3. Should be careful to avoid overfilling or dead space when applied sealer or cement 4. Use it immediately when applied sealer or cement 5. After using the paper points, should be kept in a cool place 6. Do not expose to direct sunlight 7. Do not reuse to prevent cross infections. (Secondary infections such as pathogens and viruses caused by saliva and blood)
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 20, 2020 | Still on market |
KR-MF-000009681KR19/81826259Sterile
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.
M.2025.MDR.1058AmendedNotified 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.
HZ 2020208-1AmendedNotified 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.
M.2025.MDR.1058-1WithdrawnNotified 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.
B-08806387861034On the marketprotoCORE Dual-cured core build-up compositeB-08806387861010On the marketQ01010203B-08806387807803On the marketR&S Temporary CementB-08806387860020On the marketRoyal EtchB-08806387860808On the marketRoyal flowB-08806387860778On the marketNo certificate specifically references this device's Basic UDI-DI.