Organization name

Promisemed Hangzhou Meditech Co., Ltd.

SRN

CN-MF-000008465

Manufacturer status

Active

Primary placement in Austria; available across 19 countries total.

Trade name

Alphacheck

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.

06978111920279

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.

697122740ALSNP

Reference / catalog number

ALS-01

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.

GS1

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

100

Additional product description

Suitable for disinfecting intact skin before injection and infusion.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

2 packaging levels registered — each level carries its own UDI-DI.

• 06978111920279× 100 unitsBase unit
  • 26978111920273× 20 units
    • 16978111920276× 6 units

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

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

• M0202030102NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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