BIOPORT TRICOMBO

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.
• CW032

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

  Contraindications: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, N-acetylglucosamine or to any components of KOMBIHYLAN • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding KOMBIHYLAN may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. KOMBIHYLAN should not be used in patients with known allergy to derived bovine material. KOMBIHYLAN should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.
• CW999

  KOMBIHYLAN should be administered in the synovial knee joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  Due to limited information, caution is advised regarding the KOMBIHYLAN administration in patients taking anticoagulants or antiplatelet agents.
• CW999

  Exacerbation of asthma symptoms after initiation of glucosamine supplements have been described (symptoms resolved after withdrawal of glucosamine), therefore, asthmatic patients should be aware of potential worsening of symptoms.
• CW999

  The product is administered only if the solution is clear.
• CW999

  After opening, the contents of the syringe should be used immediately.
• CW009

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 1 country total.

Trade name

BIOPORT TRICOMBO

UDI-DI code

05944728011632

Basic UDI-DI

B-05944728011632

Reference / catalog number

KOMBIHYLAN

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

KOMBIHYLAN is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. KOMBIHYLAN contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. KOMBIHYLAN is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES