Organization name

StaClear, Inc.

SRN

US-MF-000044904

Manufacturer status

Active

B994SC250AN0

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

Primary placement in Netherlands; available across 32 countries total.

Trade name

StaClear

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.

B994SC250AN0

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.

++B994SC250ANNU

Reference / catalog number

SC250AN

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

Additional information URL

https://www.staclear.com/

Clinical sizes

No clinical sizes registered for this device.

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

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

• A02010204INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE

• Class IIa medical devices in EUDAMED

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