Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Profilm Cold Sores 5mL — Class IIa MDR by i+Med S.Coop.

MD Atlas
i+Med S.Coop.

EUDAMED last updated this device on Nov 15, 2024

Profilm Cold Sores 5mL

8437015992UE0065G

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: i+Med S.Coop.
UDI-DI code: 08437015992112
Reference / catalog number: -

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
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 herpes or symptoms persist after 10 days, consult your doctor or pharmacist
CW135
o 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
CW999
Profilm Cold Sores is exclusively for external use, cutaneous application. Do not ingest the product. Do not apply Profilm Cold Sores 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.
CW262
EUDAMED did not publish a description for this code.

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 Cold Sores 5mL
UDI-DI code: 08437015992112
Basic UDI-DI: 8437015992UE0065G
Reference / catalog number: -
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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