Organization name

SPM Medicare Pvt. Ltd.

SRN

IN-MF-000011829

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• Do not use if package is damaged

  Do not use if package is damaged and consult instructions for use

• Consult instructions for use
• Do not re-use
• Do not resterilize

  Do not re-sterilize

• Check patient history for allergies to materials in the syringe.

  OTHER

Primary placement in Spain; available across 31 countries total.

Trade name

Easy Blood Collect

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.

08904379806916

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.

89043798ABS54QY

Reference / catalog number

1BQ9B1WL

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

1

Additional product description

In-Line Arterial Blood Sampling Set, BLISTER PACK, WITHOUT BUBBLE REMOVER 1ml without needle

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU03

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

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

• A02010502BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• 1000323461Issued
  Quality management systemNotified body: DQS Medizinprodukte GmbH (0297)Expiry: Aug 8, 2029