ProHeal

Organization name

Medskin Solutions Dr. Suwelack AG

SRN

DE-MF-000007747

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW267

  Treatment with ProHeal is contraindicated in patients with known hypersensitivity to bovine collagen.
• CW009

  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

  There are no clinical data on the use of ProHeal during pregnancy and lactation. The treating physician is required to make a careful risk/benefit assessment and use it only if the benefits clearly outweigh the risks
• CW999

  ProHeal should not be combined with chlorine-releasing antiseptics (e.g. chloramine), with protein-precipitating agents (tannic acid, silver nitrate) or caustic agents (iodine tinctures) that alter proteins.
• CW999

  Any serious incident with ProHeal should be reported to the Medskin Solutions Dr. Suwelack AG and the competent authority of the Member State in which the user and/or patient is established.
• CW999

  Keep all medical devices out of the reach and sight of children.
• CW999

  Disinfectants and medicinal products with tanning properties should not be used as moist dressings over the ProHeal dressing.

Primary placement in Germany; available across 4 countries total.

Trade name

ProHeal

UDI-DI code

04250569300509

Basic UDI-DI

B-04250569300509

Reference / catalog number

83032-001

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

—

Additional information URL

https://medskin-suwelack.com/proheal

Clinical sizes

• 51 MU50
• 51 MU50
• 3 MU50

• M04041001ANIMAL-DERIVED COLLAGEN DRESSINGS, NON-COMBINED

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