Organization name

Nordberg Medical AB

SRN

SE-MF-000035493

Manufacturer status

Active

D-DF001QL

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

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

• Do not use past indicated date
• Only inject JULÄINE in the deep dermis or subcutaneous layer. Avoid injecting more superficially, as this may result in the formation of papules or nodules at the injection site. Papules/ nodules could also result from injecting too much product, or from incorrect reconstitution of product. To minimize the risk of papule/nodule formation, the treated area should be massaged to ensure adequate distribution of the product.

  OTHER

• Do not resterilize
• JULÄINE should not be injected into the lip.

  OTHER

• Do not re-use
• Do not use if package is damaged
• Consult instructions for use
• JULÄINE must not be injected into the blood vessels, as this may result in vessel occlusion that could cause ischemia, skin infarction and embolism.

  OTHER

• Skin depressions should not be overfilled since they will improve over the course of several weeks as the treatment effect develops.

  OTHER

• When injecting JULÄINE, use sterile 26G needles with single-use sterile syringes.

  OTHER

• Always reconstitute the powder with sterile water for injection (Ph. Eur.) or sodium chloride solution (0.9%, Ph. Eur.) before injection, as described in INSTRUCTIONS FOR USE.

  OTHER

• Do not use JULÄINE in patients with any of the following conditions: • Acute or chronic skin disease (infection or inflammation) • History of allergies to any of the constituents of the product • Are under 18 years of age, pregnant, or breastfeeding • Haemorrhagic disease or under anticoagulant therapy • Have a known history of or susceptibility to keloid formation or hypertrophic scarring • Immune deficiencies

  OTHER

Primary placement in Sweden; available across 26 countries total.

Trade name

Juläine

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.

D-DF001QL

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-DF001QL

Reference / catalog number

DF001

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.

EUDAMED

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Sterile biodegradable PLLA dermal filler

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

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