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EUDAMED last updated this device on Jul 16, 2026
B-08806387803638ORBIS Gutta Percha Points 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.
08806387803638-(01)08806387803638
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q01010203DENTAL CONES2 warnings recorded — scroll inside the panel to see all entries.
"1.1 This product is designed to be used only for oral tissues. Please be careful to avoid eye contact. In the event of eye contact, wash the contacted eye immediately and then consult a doctor. 1.2 Non-specialists are prohibited from using this product. Do not use this product for any purposes other than its intended purposes. 1.3 Do not prescribe an internal medicine."
OTHER
KR-MF-000009681KR19/81826259Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 2, 2019 | Still on market |
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.
M.2025.MDR.1058AmendedHZ 2020208-1AmendedM.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.
View in glossary →Notified 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 →Notified 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 →B-08806387803669On the marketORBIS Gutta Percha PointsB-08806387803614On the marketORBIS Gutta Percha PointsB-08806387803645On the marketORBIS Gutta Percha PointsB-08806387803676On the marketORBIS Gutta Percha PointsB-08806387803553On the marketORBIS Gutta Percha PointsB-08806387803621On the marketNo certificate specifically references this device's Basic UDI-DI.