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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Profilm Mouth Ulcers (5ml) — Class IIa MDD by i+Med S.Coop.

MD Atlas
i+Med S.Coop.

EUDAMED last updated this device on Nov 30, 2023

Profilm Mouth Ulcers (5ml)

B-08437015992143

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: i+Med S.Coop.
UDI-DI code: 08437015992143
Reference / catalog number: PV00071

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Manufacturer information

Organization name: i+Med S.Coop.
SRN: ES-MF-000008633
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
Do not use PROFILM Mouth Ulcers if the package is damaged.
CW032
Do not use after the date marked on the package.
CW275
If you are pregnant or breastfeeding consult your doctor before using the product.
CW277
If aphthae or symptoms persist after 12 days, consult your doctor or pharmacist.
CW135
To use in children under 4 years consult with the doctor or pharmacist. Keep out of the reach of children.
CW276
Do not use with other products containing alcohol because alginate can precipitate in its presence.
CW262
EUDAMED did not publish a description for this code.
CW999
Do not ingest the product. Do not apply PROFILM Mouth Ulcers in case of hypersensitivity to any of its ingredients. Stop using the product if local hypersensitivity reactions appear in the application area. In case of any serious incident related to the product, notify the manufacturer and the competent health authority.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 14, 2021	Still on market

Device identification

Trade name: Profilm Mouth Ulcers (5ml)
UDI-DI code: 08437015992143
Basic UDI-DI: B-08437015992143
Reference / catalog number: PV00071
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 5 MU48

EMDN nomenclature code(s)

M04040501HYDROGEL DRESSINGS, NON-COMBINED

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

PV00028B-08437015992068On the market PV00029B-08437015992075On the market PV00030B-08437015992082On the market PV00025B-08437015992099On the market PV00046B-08437015992167On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.