UK MHRA: Difference between revisions
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">๐ Attachments</div> | |||
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<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">TeltoHeart Declaration of Conformity</div> | |||
<div style="font-size: 12px; color: #718096;">TeltoHeart — Class IIb</div> | |||
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<span style="background: #ebf8ff; color: #2b6cb0; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 4px 10px; border-radius: 20px;">Class IIb</span> | |||
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<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:2026-06-25, UK Declaration of Conformity TeltoHeart v1.0 Page 1.png|250px|UK Declaration of conformity page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td> | |||
<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:2026-06-25, UK Declaration of Conformity TeltoHeart v1.0 Page 2.png|250px|UK Declaration of conformity page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td> | |||
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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media:2026-06-25, UK Declaration of Conformity TeltoHeart v1.0.pdf|UK Declaration of Conformity Class IIb โ]]''' | |||
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Latest revision as of 09:19, 9 July 2026
Main Page > TeltoHeart > UK MHRA
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UK MHRA
Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.
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๐ Regulatory Details
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Device Name
TeltoHeart
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Trade Name
TeltoHeart
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Device Type
Physiologic Monitor / Medical Device Software
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GMDN Code
66625
Physiologic Monitor โ Installed Software
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UK Medical Device Classification
Class IIb
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Applicable Regulation
UK Medical Devices Regulations 2002
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๐ Declaration of Conformity
We, UAB Teltonika Telemedic, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of the UK Medical Devices Regulations 2002.
๐ฌ๐ง MHRA Registration Information
The device is registered with the Medicines and Healthcare products Regulatory Agency (MHRA):
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MHRA Reference Number
33173
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Date Registered
23/10/2024
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Manufacturer
UAB Teltonika Telemedic
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Manufacturer Address
Ukmergฤs g. 120-1, Vilnius, Lithuania LT-08126
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Customer Service Email
Not Available
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Customer Service Telephone Number
Not Available
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UK Responsible Person / NI Authorised Representative
Teltonika United Kingdom Ltd
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Relationship
UK Responsible Person
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Representative Address
Suite G1, Building 8 Quay Exchange, Salford, England, United Kingdom M5 3EJ
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Device Brand / Trade Name
TeltoHeart
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GMDNยฎ Code
66625
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Device Registration Status
Registered
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Medical Device Risk Classification
Class IIb
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๐ Attachments
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TeltoHeart Declaration of Conformity
TeltoHeart — Class IIb
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Class IIb |
 Page 1 |
 Page 2 |
Download PDF version of the declaration: UK Declaration of Conformity Class IIb โ
External Links