Organization name

BIOTEC S.R.L.

SRN

IT-MF-000026774

Manufacturer status

Active

• 007-00-06-MDRSupplemented
  Quality management systemNotified body: 0426Expiry: Dec 20, 2027
• 008-00-04-MDRSupplemented
  Technical documentationNotified body: 0426Expiry: Dec 20, 2027

+D748247CC1A10-

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

Primary placement in Italy; 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.

+D748247CC1A10-

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.

++D748CADCAMBASE89

Reference / catalog number

247CC1A1

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.

HIBCC

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 IIb

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 IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.