Eleview

Organization name

Cosmo Technologies

SRN

IE-MF-000024119

Manufacturer status

Active

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

• CW010

  Consult instructions for use (Symbol)
• CW007

  Do not use if package is damaged (Smybol)
• CW009

  Eleview should not be reused after first opening
• CW032

  Do not use after expiry date
• CW999

  The Endoscopist injecting Eleview must be experienced in the administration technique
• CW999

  The safety of Eleview has not been established in pregnant or lactating women or in children under 18 years of age.
• CW999

  Eleview is provided in single use ampoules. Eleview should not be reused after first opening. Any emulsion not injected during the procedure should not be reused for another endoscopic procedure
• CW999

  Do not use if the primary packaging (ampoule) or secondary packaging (aluminum pouch) is damaged
• CW999

  Do not use if twist-off cap is damaged
• CW999

  Do not use if emulsion is not clear, shows any signs of opalescence or contains floating or precipitated visible particles.
• CW999

  The product compatibility with other substances has not been tested

Primary placement in Romania; available across 17 countries total.

Trade name

Eleview

UDI-DI code

05391530190008

Basic UDI-DI

B-05391530190008

Reference / catalog number

9000023

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

SUBMUCOSAL INJECTABLE COMPOSITION TO FACILITATE ENDOSCOPIC RESECTION PROCEDURES 10 mL

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• G0399DIGESTIVE ENDOSCOPY DEVICES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.