Organization name

Aptos LLC

SRN

GE-MF-000020012

Manufacturer status

Active

4860120240061

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

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Primary placement in Czechia; available across 30 countries total.

Trade name

APTOS

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

4860120240061

Basic UDI-DI

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.

B-4860120240061

Reference / catalog number

ASS024

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

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.

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Aptos Spring Soft is non-absorbable Polypropylene monofilament thread spirally wrapped around the needle. monofilament is dyed blue with non-irritating dye, which is approved for use in medical devices. The thread has a hydrophobic and smooth surface. In this particular product, the shape of the thread has been modified mechanically to achieve spring – spiral – like look. Aptos Spring Softies design is used to achieve ease of delivery/implantation of the entire thread into sub dermal tissue. Visible esthetic effect is observed during 3-3,5 year. The procedure might be held in ambulatory, using local anesthetics. Rehabilitation lasts about 5-6 days.

Additional information URL

https://eifu.aptos.global/

Clinical sizes

• 440–470 MU50

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• H010201010401POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.