Organization name

Shandong Huge Dental Material Corporation

SRN

CN-MF-000013266

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  Not for etching of tooth surface or any application in the oral cavity.
• CW010

  Hydrofluoric acid is a very powerful, aggressive and toxic chemical. Direct contact may cause allergic reactions, skin irritation or inflammation, leading to tissue damage. Hydrofluoric acid also releases a vapor that irritates respiratory passageways. Chronic inhalation of fumes is dangerous and can cause damage. Contains HF acid. Avoid contact with skin, eyes and soft tissue. In case of contact with skin or eyes, flush immediately with water. Get medical attention immediately. Do not take internally. Hydrofluoric acid is corrosive to quartz, silicate and borate glasses, as well as sanitary ceramics and various metals and alloys (e.g. high-grade steel). Dispensing Tips are for single use only, to prevent cross-contaminations between patients. If there is spill of the HF gel, pour sufficient amount of base natured chemicals such as Baking Soda, Calcium Hydroxide, etc. to the spilled material to neutralize the acid immediately. Then clean the site with water, or wipe it off with proper materials and discard following local environmental regulations. Wear acid resistant gloves and eye protection goggles when using and handling the HF acid gel. Keep away where children may reach.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

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.

06909412329263

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.

697222048HFE1017K

Reference / catalog number

E9/1.2ml

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

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.

• Q010299PROSTHETIC DENTISTRY DEVICES - OTHER

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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