DSM Biomedical

SRN: US-MF-000021393 · Pennsylvania Drive 735, 19341 Exton , United States

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

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Basic Information

Address: Pennsylvania Drive 735, 19341 Exton , United States
Email: [email protected]
Phone: +1 484 713 2100
Website: https://www.dsm.com/biomedical/en_US/home-biomedical.html

Regulatory Overview

Regulation

Eu Mdd 48

Classification

Eu Md Class 3 48

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Expiry Date
MDD Annex II Section 4	583404	BSI Group The Netherlands B.V.	Jan 01, 2023
MDD Annex II Section 4	686790	BSI Group The Netherlands B.V.	Jan 01, 2023
MDD Annex II Section 4	552477	BSI Group The Netherlands B.V.	May 26, 2024
MDD Annex II Section 4	552587	BSI Group The Netherlands B.V.	May 26, 2024
MDD Annex II Section 4	558748	BSI Group The Netherlands B.V.	May 26, 2024

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
Arthrex DX Reinforcement Matrix, Hydrated 5cm x 5cm	EU MDD	Eu Md Class 3	On Market	1
Arthrex DX Reinforcement Matrix, Hydrated 6cm x 8cm	EU MDD	Eu Md Class 3	On Market	1
CopiOs Bone Void Filler - Sponge 10cc	EU MDD	Eu Md Class 3	Off Market	1
CopiOs Bone Void Filler - Sponge 10cc	EU MDD	Eu Md Class 3	Off Market	1
CopiOs Bone Void Filler - Sponge 1cc	EU MDD	Eu Md Class 3	Off Market	1
CopiOs Bone Void Filler - Sponge 1cc	EU MDD	Eu Md Class 3	Off Market	1
CopiOs Bone Void Filler - Sponge 5cc	EU MDD	Eu Md Class 3	Off Market	1
CopiOs Bone Void Filler - Sponge 5cc	EU MDD	Eu Md Class 3	Off Market	1
Epi-Guide Bioresorbable Barrier Matrix	EU MDD	Eu Md Class 3	Off Market	1
Meso BioMatrix, Preshaped 10 cm x 20 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Preshaped 8 cm x 16 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 10 cm x 16 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 10 cm x 20 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 2 cm x 4 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 4 cm x 5 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 6 cm x 16 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 6 cm x 8 cm	EU MDD	Eu Md Class 3	On Market	1
Meso BioMatrix, Rectangular 8 cm x 16 cm	EU MDD	Eu Md Class 3	On Market	1
Neomem ECM Dental Membrane 15 mm X 20 mm	EU MDD	Eu Md Class 3	On Market	1
Neomem ECM Dental Membrane 20 mm X 30 mm	EU MDD	Eu Md Class 3	On Market	1
Neomem ECM Dental Membrane 30 mm X 40 mm	EU MDD	Eu Md Class 3	On Market	1
SICmeso Guard Dental Membrane 15 mm X 20 mm	EU MDD	Eu Md Class 3	On Market	1
SICmeso Guard Dental Membrane 20 mm X 30 mm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 10cm x 16cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 10cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 12cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 16cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 16cm x 25cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 20cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 20cm x 25cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 20cm x 30cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 20cm x 40cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 25cm x 40cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 25cm x 45cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 2cm x 4cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 4cm x 16cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 4cm x 7cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 5cm x 16cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 6cm x 12cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 6cm x 16cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 6cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 8cm x 12cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 8cm x 16cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Hydrated 8cm x 20cm	EU MDD	Eu Md Class 3	On Market	1
XCM Biologic™ Tissue Matrix, Tailored Coverage, Hydrated 25cm x 35cm	EU MDD	Eu Md Class 3	On Market	1
Zmatrix Porcine Peritoneum Collagen Membrane 15 mm X 20 mm	EU MDD	Eu Md Class 3	On Market	1
Zmatrix Porcine Peritoneum Collagen Membrane 20 mm X 30 mm	EU MDD	Eu Md Class 3	On Market	1
Zmatrix Porcine Peritoneum Collagen Membrane 30 mm X 40 mm	EU MDD	Eu Md Class 3	On Market	1

PRRC

Name

John George

Country

🇺🇸 United States

Authorized Representative

Name

DSM Biomedical B.V.

Country

🇳🇱 Netherlands

Notified Bodies

BSI Group The Netherlands B.V.

5 certs

Competent Authority

Name

Ministry of Health, Welfare and Sports

Country

🇳🇱 Netherlands

More about this competent authority →

PSUR Report

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