1. table of contents (page 1) 4. european test & technical

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1. Table of Contents (Page 1) 2. Basic Information (Page 2) 3. Packaging & Pictures (Page 3-4) 4. European Test & Technical Documentation Review Report (Page 5-12) 5. Registration on DIMDI & Declaration of Conformity (Page 13-14) 6. ISO Production Standards Report (Page 15-22) 7. Manufacturer Qualification Certificate & Export License (Page 23-25) P1

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Page 1: 1. Table of Contents (Page 1) 4. European Test & Technical

1. Table of Contents (Page 1)

2. Basic Information (Page 2)

3. Packaging & Pictures (Page 3-4)

4. European Test & Technical Documentation Review Report

(Page 5-12)

5. Registration on DIMDI & Declaration of Conformity (Page

13-14)

6. ISO Production Standards Report (Page 15-22)

7. Manufacturer Qualification Certificate & Export License

(Page 23-25)

P1

Page 2: 1. Table of Contents (Page 1) 4. European Test & Technical

Disposable Medical Face Mask Inherent-Type IIR Earloop

Brand: Inherent

Type No.: YX011 (Earloop)

Performance standard: EN 14683:2019 + AC:2019(E) Annex B

/C/D & YY/T 0969-2013, tested by TÜV Rheiland & Intertek

Production standards: ISO 10933-10:2010 & ISO 10993-

5:2009, tested by CCIC

Classifications: Type IIR Earloop (Non-

Sterile), No latex ingredients

Material: Two-layer PP Nonwoven fabric and One-

layer BFE95 Meltblown fabric (3 layers)

Mask specifications: Universal, 17,50 x 9,50 cm

Earloop design: Breathable and comfortable for prolonged w

earing

Expiration date: 2 years from the date of manufacture

P2

Page 3: 1. Table of Contents (Page 1) 4. European Test & Technical

Packing specifications: 10 pcs. / PE bag, 50 pcs. /

box, 40 boxes 2000 pcs. / carton, 16 cartons / euro pallet

Carton measurements: 51.5 x 39 x 35.5 cm, G.W. 9.1 KGS.

Stock available: Rotterdam The Netherlands, Frankfurt a/m

Germany and Madrid Spain

P3

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