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Angiography Pack - NL1


BRIEF DESCRIPTION

Angiography Pack

PRODUCT CODE

05-117415AA-03

COUNTRY OF ORIGIN

The Netherlands

TRADE NAME

PACK ANGIO NL1

APPROVAL BY THE NATIONAL ORGANIZATION FOR MEDICINES (NOM)

2820007843367

PACK ANGIO NL1 is a complete, high quality interventional cardiology procedure pack designed to meet the needs of the radiology laboratory during angiography procedures.

It is a ready to use solution that includes all essential medical consumables for angiography procedures, contributing to reduced preparation time while maintaining full sterility throughout the process.

It is manufactured using high quality materials, sourced only from certified suppliers in the USA, the United Kingdom, and Europe. Final assembly and packaging take place in the Netherlands by Medica Europe B.V., in compliance with strict quality standards and the European Regulation EU 2017/745 (MDR).


Package Contents

PACK ANGIO NL1 is a complete angiography procedure set that includes the following components:

 

S/N

DESCRIPTION

UNIT

1

DRAPE FEM 3PLY radiographic table drape with 2 openings for femoral access and transparent along both sides 318X190cm, Blue

1

2

Surgical Table Cover 195 Χ 150cm, (waterproof, lined, absorbent), Blue

1

3

Transparent protective cover 107 Χ 102cm, square

1

4

Transparent protective cover 91 Χ 51cm, square

1

5

Medical gown size: XL lined and hypoallergenic

2

6

Hand towel 42.5 X 30.5cm

2

7

10x10cm Gauze, 12ply

40

8

Round Bowl 250ml, Blue

1

9

Round Bowl  500ml,  Blue

2

10

Round Bowl  6000ml, Blue

1

11

3 way stopcock, red

1

12

5ml Syringe, Luer lock

1

13

10ml Syringe, Luer lock

2

14

20ml Syringe, Luer lock

2

15 Scalpel No.11 with 13cm plastic handle 1
16

Special sponge with plastic handle 15cm, for Betadine of foerster clamp type

1

 

Key Benefits

  • CE MDR Compliance: Class IIa medical device in accordance with EU Regulation 2017/745
  • Complete set: All necessary components in a single, integrated package
  • Reduced preparation time: Ready to use solution for faster and more efficient setup
  • Consistent high quality: Carefully selected consumables from internationally certified suppliers
  • Optimized logistics: Simplifies inventory and procurement management
  • Full traceability: LOT and Reference Number indicated on each package

Certifications & Packaging

The product is supplied:

  • Sterile
  • Single-use

and complies with the following standards:

  • ISO 13485:2016
  • EN ISO 13485:2016
  • CE marking in accordance with EU Regulation 2017/745 (MDR)
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