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EUDAMED last updated this device on Jun 29, 2026
B-08806387805632Aurum Blue 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.
08806387805632-KR-MF-000009681KR19/81826259(01)08806387805632
1 warning recorded — scroll inside the panel to see all entries.
"① Do not use this product for any patients with a history of hypersensitivity reactions to it, such as a rash, dermatitis, etc. ② Some patients have an allergic reaction to Trans 1,4 Polyisoprene materials and/or even experience hypersensitivity. Do not use this product for them ③ This product is intended only for use for the tissue inside the mouth. Be careful to prevent it from coming into contact with eyes. If material has come into contact with eyes or skin, wash immediately with plenty of water and then consult a doctor. ④ Non-specialists are prohibited from using this product. Do not use this product for any purposes other than its intended purposes. ⑤ Do not prescribe an internal medicine ⑥ Should be careful to avoid overfilling or dead space ⑦ Be sure to take measures for the protection of the respiratory tract before ⑧ Always close the slide lid after use space ⑨ Do not reuse. Reusing these products increases the risk of cross-contamination and/or breakage."
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 Germany; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jun 25, 1998 | Still on market |
| EL | Jun 25, 1998 | Still on market |
| Spain | Jun 25, 1998 | Still on market |
| France | Jun 25, 1998 | Still on market |
| Italy | Jun 25, 1998 | Still on market |
| Portugal | Jun 25, 1998 | Still on market |
| Türkiye | Jun 25, 1998 | Still on market |
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.
Q01010203DENTAL CONESPrimary 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 →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 →No certificate specifically references this device's Basic UDI-DI.
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