- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Nov 9, 2023
B-05411834092119PROTEX X-LARGE is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Innolatex (Thailand) Limited. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05411834092119P56S(01)05411834092119
European Medical Device Nomenclature — the EU product classification assigned to this device.
U110101CONDOMS6 warnings recorded — scroll inside the panel to see all entries.
Do not use the condom if the rubber materials are sticky or brittle. If the individual container is obviously damaged, discard that condom and use a new one from an undamaged package.
The condoms and the wings are for single use only; reused condom could increase the risk of breakage and infection.
For maximum benefit, carefully follow the condom instructions inside this package.
This product contains natural rubber latex which may cause allergic reactions including anaphylactic shock. If you are allergic to natural rubber latex products, consult your doctor for advice before use. There is a risk of choking using a condom orally.
Do not use oil-based lubricants such as petroleum jelly, mineral oil and cold cream, as they may weaken the condom and cause subsequent failure of the product. So can some topical medicines that are applied to the penis or vagina. If you are not sure about the effect of the medicines you’re using on condoms, ask your doctor or pharmacist. Seek medical assistance as soon as possible, at least within 72hour should a condom leak or burst during use. No method of contraception can provide 100% protection against pregnancy or transmission of HIV and STIs. If you suspect that you or your partner may have become pregnant or infected, consult your doctor immediately.
Primary placement in Denmark; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | — | Still on market |
TH-MF-000001249G1 105104 0002OTHER
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.No certificate specifically references this device's Basic UDI-DI.