Organization name

Nobel Biocare AB

SRN

SE-MF-000000009

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not re-use

Primary placement in Sweden; available across 31 countries total.

Trade name

Surgical Template Fully Guided, 6 implants

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.

07332747079258

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.

73327470000001857H

Reference / catalog number

75590

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

https://ifu.nobelbiocare.com/

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.

• Q010399SURGICAL DENTAL DEVICES - OTHER

• Class I medical devices in EUDAMED

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