CE Certificate

CE Certificate

CE Certificate

Product catalog summary
Certificate Overview:
The document is a certificate under Article 11 of Regulation (EU) 2017/745 concerning medical devices. It confirms that AF Pharma Service Europe SL is the European authorized representative for Medicta Instruments, located in Sialkot, Pakistan, for Class I medical devices.

Authorized Representative Details:
AF Pharma Service Europe SL, based in Barcelona, Spain, acts as the authorized representative under Actor ID/SRN - ES-AR-000018076.

Agreement and Compliance:
The EAR Service Agreement, effective from May 2022, outlines the terms and conditions. The manufacturer is responsible for product liability and compliance with MDR 2017/745. The CE marking is to be affixed after fulfilling EU legislation requirements.

Certificate Validity:
The certificate is valid from September 1, 2022, to September 1, 2023. It is not a product notification or market approval certificate and becomes void if the EAR Agreement is terminated or relevant legislation changes.

Device Registration:
The devices listed in Annexure-A are registered with the Spanish Ministry of Health and the EUDAMED Database.

Annexure-A: List of Devices
The annexure includes a comprehensive list of dental and surgical instruments such as tooth extracting forceps, root elevators, bone rongeurs, dental syringes, and various forceps, among others. All devices are marked as N/A for UDI EC Cert ID.

Contact Information:
AF Pharma Service Europe SL can be contacted via email at [email protected] or through their website www.afpharmaservice.com. An urgency phone number is also provided: +34 648988915.
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Catalog excerpts

CE Certificate-1

Article 11 of Regulation (EU) 2017/745 on Medical Device The European Authorized Representative Center, AF Pharma Service Europe SL confirmed it has assumed the role of European authorized representative of the Medicta Instruments Located at: PO Gohad Pur Head Marala Road, Sialkot ‐ 51310, Pakistan for Product Categories Medical Devices class I, please see Annexure-A List of Devices with terms and conditions set out in EAR Service Agreement which entered into force on May 2022 and the mandate is signed by both parties in accordance with article 11.2 of MDR (EU) 2017/745. The product liability rests with the manufacturer in accordance with applicable directive and standard, after fulfilling of the relevant EU legislation requirements, the manufacturer shall affix relevant CE marking to medical devices mentioned in Annexure-A. The products in Annexure-A was registered in Spanish MOH and in EUDAMED Database. Valid from: 2022-09-01 Valid until: 2023-09-01 Issue Date This certificate is neither a certificate of product notification nor an approval to place product on the market. The certificate has no legal value and become void automatically upon termination EAR Agreement or rejection of products from PRRC of AF Pharma Service or relevant legislation are changed. The validity is conditioned by information supplied by the manufacturer. The manufacturer is sole responsible for the MDR 2017/745 compliance. AF Pharma Service is playing role of Authorized Represented under Actor ID/SRN - ES-AR-000018076 Registered Address: AF Pharma Service Europe SL, Muntaner – 281, City: Barcelona España Postal Code 08021, Country: Spain - Contact information: [email protected], www.afpharmaservice.com Urgency phone: +34 6489889

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CE Certificate-2

Valid up to 01 Year from Date of Issuance Annexure-A List of Devices Issue Date Dental Instruments Tooth Extracting Forceps Root Elevator Bone Rongeurs Bone Chisels Bone Curettes Needle Holders Mouth Gags Dental Scalers Dental Dressing Forceps Rubber Dam Clamps Forceps Rubber Dam Punch Forceps Orthodontic Pliers Amalgam Instruments Dental Cheek Retractor Dental Surgical Scissors Crown Scissors Dental Syringes Dental Spatula Dental Mirror Bone File/Rasp Impression Trays Dental Articulator Surgical Instruments Scissors Dressing Forceps

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CE Certificate-3

Mosquito Forceps Pean Forceps Kelly Forceps Crile Forceps Needle Holders Splinter Forceps Towel Clamps Sponge Forceps Thumb Forceps Tissue Forceps Retractors Hooks Probes Vaginal Speculums Vaginal Dilators Biopsy Forceps Towel Forceps Otoscope Set Laryngoscope Handles Laryngoscope Blades Dermatoscope Ophthalmoscopes Percussion Hammers Suction Cannulas Scalpel Handles Scalpel Surgical Sets Dissecting Kit Instrument Tray Sterilization/Disinfection Container Forceps Jar Emesis Bowl General-Purpose Bowl Bedpan Bone Cutters Mallets Knives Curettes Bone Cutting Forceps Bone Holding Forceps

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CE Certificate-4

Uterine Sound Surgical Spatula AF Pharma Service is playing role of Authorized Represented under Actor ID/SRN - ES-AR-000018076

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.