Absorbent Paper Points

Organization name

META BIOMED CO., LTD.

SRN

KR-MF-000009681

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  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 8 countries total.

Trade name

Absorbent Paper Points

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08806387824190

Basic UDI-DI

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.

B-08806387824190

Reference / catalog number

-

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

“Hand”rolled for extra absorbency - Highly absorbent - Length marked available - Variety sizes and packages available - Color coded

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q01010401PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.