Disposable mask type II 077

Product catalog summary

Product Overview:
The document describes a Type II disposable surgical mask manufactured in Italy by Plus Biomedicals srl. It is a Class 1 medical device compliant with Directive 93/42/CEE and ISO 14683:2019 standards. The mask is composed of three layers: an inner layer of spunbond polypropylene (30 g/m²), a middle layer of meltblown polypropylene (25 g/m²), and an outer layer of spunbond polypropylene (25 g/m²). The mask is hypoallergenic and features a heat-sealable elastic band that is latex-free.

Specifications:
- Dimensions: 100x180 mm
- Packaging: Available in packs of 50 pieces
- Elastic Band: 70% nylon, 30% elastomer, diameter 2.50mm, elongation 250%
- Lug Twistband: Fe/pp food contact grade, 1x0.58mm
- EAN Code: 8 052282 620089
- Registration Number: 2033618

Certification and Compliance:
The company is ISO 13485:2016 certified, ensuring quality management in the design, production, and marketing of surgical masks. The certificate is valid from October 16, 2020, to October 15, 2023, subject to annual audits and a triennial reassessment.

Contact Information:
Plus Biomedicals Srl, Via L.Abbiati, 22A - 25134 Brescia, Email: [email protected], Phone: 030 0982904, VAT: 04056080981.

Additional Notes:
The product is 100% made in Italy and adheres to all traceability regulations. Further clarifications regarding ISO 13485:2016 requirements can be obtained by consulting the organization.

Catalog excerpts

DISPOSABLE SURGICAL MASKS TYPE II

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mascherine CHIRURGICHE MONOUSO tipoii SECONDO LA NORMA UN! EN 14683:2019 CLASS 1 MEDICAL DEVICE ACCORDING CERTIFIED COMPANY WITH ISO TO DIRECTIVE 93/42/CEE QUALITY SYSTEM 13485:2016

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■ Product name: Disposable mask type II 077 Registration number as a medical device: 2033618 (see more on the website of the Ministry of Health: www.salute.gov.it) the product is 100% Made in Italy and 8 052282 620089 follows all traceability regulations. I Producer: Plus Biomedicals srl Dimensions: 100x180 mm available in packs of 50 pz Product description: Triple layer surgical mask with filtering capacity and characteristics in accordance with ISO 14683:2019. Internal layer and hypoallergenic filter made of Spun-bond 30 g/m2, world side layer made of TNT Spunbond 25g/m2, intermediate layer...

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SI CERTIFICA CHE IL SISTEMA DI GESTIONE PER LA QUALITA' DI WE HEREBY CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM OPERATED BY PLUS BIOMEDICALS SRL VIA CAMILLO BROZZONI 9 - 25125 BRESCIA (BS) UNITA' OPERATIVE / OPERATIVE UNITS Vedere gli Allegati per le Unità Operative (n° 2 allegati) View the Annexes for the Operative Units (n° 2 annexes) E' CONFORME ALLA NORMA / IS IN COMPLIANCE WITH THE STANDARD ISO 13485:2016 PER LE SEGUENTI ATTIVITA' / FOR THE FOLLOWING ACTIVITIES  Progettazione, produzione e immissione in commercio di mascherine chirurgiche Design, production and placing on the market of...

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Think Human, Think For Human Plus Biomedicals Srl Via L.Abbiati, 22A - 25134 Brescia [email protected] Phone: 030 0982904 VAT: 04056080981

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Disposable mask type II 077

Disposable mask type II 077

Catalog excerpts

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