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EUDAMED last updated this device on Jan 21, 2025
B-08800125100706Muli-A is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by PRP Science Co., Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08800125100706Not applicable(01)08800125100706
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12040203DERMAL REGENERATION EQUIPMENT1 warning recorded — scroll inside the panel to see all entries.
1. The product should be injected only into the lower layers of the dermis or the layers of the hypodermis. 2. Like other injections, in cases of the patients who have been administered anticoagulants, the product may carry the risk of haematoma or local bleeding in the injection site. 3. Do not inject the product at a shallow depth, closer to the outer layer of the skin, in order to prevent early papules or nodules at the injection site. 4. If the product is injected into blood vessels, it may obstruct the blood vessels or their flow, and cause skin embolism. 5. In order to avoid contamination, each vial package must be used for one single patient only. Since the product is a disposable single-use material, do not re-use or re-sterilize after opening its seal or reconstituting the solution. 6. If the sealed package is broken, damaged or modified, do not use the product. 7. It is strictly prohibited to use the product for other purposes except its originally intended purpose. 8. Before treatment, make sure that the prepared product has completed the reconstitution as it is indicated in the preparation guideline of the product. 9. A sterile, disposable 26G needle or cannula must be used for this injection treatment.
Primary placement in Ireland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Jan 17, 2025 | Still on market |
KR-MF-0000144501434-MDD-106/20211434-MDD-107/2021Sterile
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 certificate specifically references this device's Basic UDI-DI.
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.