Rafael GARCÍA MEIRO Chief Executive Officer

Michael Drechsel

President of IQNet

IQNet and AENOR

hereby certify that the organization

ELECTRO PLAS, S.A. (ELECTROPLAST)

1,5 Km de Noroeste de la Antigua Guardia Rural de Santa Rosa.

SANTO DOMINGO DE HEREDIA Costa Rica

for the following field of activities

Injection molding and assembly of plastic parts to be used as a component for medical devices.

has implemented and maintains a

Medical devices Quality Management Systems

which fulfills the requirements of the following standard

ISO 13485:2016

First issued on:

2018-05-17

Validity date: 2021-05-17

ES-GS-0003/2018 a

Certificado de Registro de EmpresaConforme a las exigencias de la norma

INTE/ISO 14001:2015Sistemas de gestión ambiental. Requisitos.

La Asociación Instituto de Normas Técnicas de Costa Rica, INTECO, ubicada en San José, Costa Rica, certifica que la organización:

National Institute of Standarization Association of Costa Rica, INTECO – San José, Costa Rica, certifies that the organization:

ELECTROPLAST S.A.

Director de Servicios de Evaluación

Fecha de emisión: 1997/04/24 Fecha de renovación : 2020/04/27 Fecha de expiración: 2023/04/24

El presente certificado es válido exclusivamente para el proceso descrito, no tiene validez sin su correspondiente alcance de la certificación, donde se indica el servicio, las especificaciones y los documentos normativos aplicables, así como número de registro. En caso de duda siempre prevalecerá el alcance en español. This certificate is valid only for the process described, is not valid without a corresponding scope of certification, indicating the services, specifications and normative documents, and registration number. In case of doubt the spanish written scope will prevail over the english written scope. RS-SE-93. Versión #2. Revisión #1

MS: ISO 9001, Product

INTE/ISO 14001:2015

SISTEMA DE GESTIÓN AMBIENTAL

CERTIFICADO

Cumple con los requisitos para el siguiente alcance:Producción ,ensamble y distribución de piezas plásticas por medio del proceso de inyección

dirigidas a la industria médica, de higiene, electrónica, entre otros según requisitos del cliente.

Complies with the requirements for the following scope:Production, assembly and distribution of plastic parts through the injection process directed to

the medical industry, hygiene, electronics, among others accordint to clients requirements.

Que opera en las instalaciones ubicadas en:which is carried out in :

Heredia, Santa Rosa de Santo Domingo, 1.5 km al noroeste de la antigua Guardia Rural.

SGA-002/01/1999

CERTIFICATEINTECO has issued an IQNet recognized certificate that the organization:

ELECTROPLAST S.A HEREDIA,COSTA RICA.

has implemented and maintains a

Environmental management systems. Requirements with guidance for use.

PRODUCTION, ASSEMBLY AND DISTRIBUTION OF PLASTIC PARTS THROUGH THE INJECTION PROCESS DIRECTED TO THE MEDICAL INDUSTRY, HYGIENE, ELECTRONICS, AMONG OTHERS ACCORDINT TO CLIENTS REQUIREMENTS.

which fulfils the requirements of the following standard:

INTE/ISO 14001:2015

Jonathan Peréz Assesment Services Director

Alex StoichitoiuPresident of IQNet

This attestation is directly linked to the IQNet Partner’s original certificate and shall not be used as a stand-alone document

Issued on: 1997/04/24 Expires on: 2023/04/24

IQNet Partners*:AENOR Spain AFNOR Certification France APCER Portugal CCC Cyprus CISQ Italy CQC China CQM China CQS Czech Republic Cro Cert Croatia DQS Holding GmbH

Germany EAGLE Certification Group USA FCAV Brazil FONDONORMA Venezuela ICONTEC Colombia Inspecta Sertifiointi Oy Finland INTECO Costa Rica IRAM Argentina JQA Japan KFQ Korea MIRTEC Greece MSZT Hungary Nemko AS Norway NSAI Ireland NYCE-SIGE México PCBC Poland Quality Austria Austria RR Russia SII Israel

SIQ Slovenia SIRIM QAS International Malaysia SQS Switzerland SRAC Romania TEST St Petersburg Russia TSE Turkey YUQS Serbia

* The list of IQNet partners is valid at the time of issue of this certificate. Updated information is available under www.iqnet-certification.com

Registration Number: CR-SGA-002/01/1999

Complies with the requirements for the following scope:

Certificado de Registro de EmpresaConforme a las exigencias de la norma

INTE/ISO 9001:2015Sistemas de gestión de la calidad. Requisitos.

La Asociación Instituto de Normas Técnicas de Costa Rica, INTECO, ubicada en San José, Costa Rica, certifica que la organización:

National Institute of Standarization Association of Costa Rica, INTECO – San José, Costa Rica, certifies that the organization:

ELECTROPLAST S.A.

Director de Servicios de Evaluación

Fecha de emisión: 1997/04/24 Fecha de renovación : 2020/04/27 Fecha de expiración: 2023/04/24

El presente certificado es válido exclusivamente para el proceso descrito, no tiene validez sin su correspondiente alcance de la certificación, donde se indica el servicio, las especificaciones y los documentos normativos aplicables, así como número de registro. En caso de duda siempre prevalecerá el alcance en español. This certificate is valid only for the process described, is not valid without a corresponding scope of certification, indicating the services, specifications and normative documents, and registration number. In case of doubt the spanish written scope will prevail over the english written scope. RS-SE-93. Versión #2. Revisión #1

MS: ISO 9001, Product

INTE/ISO 9001:2015

SISTEMA DE GESTIÓN DE CALIDAD

CERTIFICADO

Cumple con los requisitos para el siguiente alcance:Producción ,ensamble y distribución de piezas plásticas por medio del proceso de inyección

dirigidas a la industria médica, de higiene, electrónica, entre otros según requisitos del cliente.

Complies with the requirements for the following scope:Production, assembly and distribution of plastic parts through the injection process directed to

the medical industry, hygiene, electronics, among others accordint to clients requirements.Que opera en las instalaciones ubicadas en:

which is carried out in :Heredia, Santa Rosa de Santo Domingo, 1.5 km al noroeste de la antigua Guardia Rural.

RE-002/01/1997

CERTIFICATEINTECO has issued an IQNet recognized certificate that the organization:

ELECTROPLAST S.A HEREDIA,COSTA RICA

has implemented and maintains a

Quality Management Systems. Requirements.

Complies with the requirements for the following scope:

PRODUCTION, ASSEMBLY AND DISTRIBUTION OF PLASTIC PARTS THROUGH THE INJECTION PROCESS DIRECTED TO THE MEDICAL INDUSTRY, HYGIENE, ELECTRONICS, AMONG OTHERS ACCORDINT TO CLIENTS REQUIREMENTS.

which fulfils the requirements of the following standard:

INTE/ISO 9001:2015

Jonathan Peréz Assesment Services Director

Alex StoichitoiuPresident of IQNet

This attestation is directly linked to the IQNet Partner’s original certificate and shall not be used as a stand-alone document

Issued on: 1997/04/24 Expires on: 2023/04/24

IQNet Partners*:AENOR Spain AFNOR Certification France APCER Portugal CCC Cyprus CISQ Italy CQC China CQM China CQS Czech Republic Cro Cert Croatia DQS Holding GmbH

Germany EAGLE Certification Group USA FCAV Brazil FONDONORMA Venezuela ICONTEC Colombia Inspecta Sertifiointi Oy Finland INTECO Costa Rica IRAM Argentina JQA Japan KFQ Korea MIRTEC Greece MSZT Hungary Nemko AS Norway NSAI Ireland NYCE-SIGE México PCBC Poland Quality Austria Austria RR Russia SII Israel

SIQ Slovenia SIRIM QAS International Malaysia SQS Switzerland SRAC Romania TEST St Petersburg Russia TSE Turkey YUQS Serbia

* The list of IQNet partners is valid at the time of issue of this certificate. Updated information is available under www.iqnet-certification.com

Registration Number: CR-RE-002/01/1997