DF001

Organization name

Nordberg Medical AB

SRN

SE-MF-000035493

Manufacturer status

Active

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

• CW032

  EUDAMED did not publish a description for this code.
• CW999

  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.
• CW001

  EUDAMED did not publish a description for this code.
• CW999

  JULÄINE should not be injected into the lip.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  JULÄINE must not be injected into the blood vessels, as this may result in vessel occlusion that could cause ischemia, skin infarction and embolism.
• CW999

  Skin depressions should not be overfilled since they will improve over the course of several weeks as the treatment effect develops.
• CW999

  When injecting JULÄINE, use sterile 26G needles with single-use sterile syringes.
• CW999

  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.
• CW999

  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

Primary placement in Sweden; available across 26 countries total.

Trade name

not provided

UDI-DI code

D-DF001QL

Basic UDI-DI

B-DF001QL

Reference / catalog number

DF001

Issuing entity

EUDAMED

Risk category

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

D-DF001QL

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

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES