Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - RF Medical Co. Ltd.

Address:

#502~507 511 601 World Meridian 254 Beot kkot-ro Geumcheon-gu Seoul Korea

Seoul

8511

South Korea

Authorised Representative/ UK Responsible Person
Name: Obelis UK Ltd
Address:

Sandford Gate East Point Business Park

Oxford

OX4 6LB

England United Kingdom

Code/Term Type

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Class IIb

Percutaneous radio-frequency ablation probe tumour-ablation monopolar Percutaneous radio-frequency ablation probe tumour-ablation monopolar Class IIb

Open-surgery electrosurgical handpiece/electrode bipolar single-use Open-surgery electrosurgical handpiece/electrode bipolar single-use Class IIb

Peripheral vascular electrocautery catheter single-use Peripheral vascular electrocautery catheter single-use Class IIb

Epidural anaesthesia set non-medicated Epidural anaesthesia set non-medicated Class IIa

Soft-tissue biopsy procedure kit non-medicated Soft-tissue biopsy procedure kit non-medicated Class IIa

Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Class IIa

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Percutaneous radio-frequency ablation system generator	Percutaneous radio-frequency ablation system generator	Class IIb
Percutaneous radio-frequency ablation probe tumour-ablation monopolar	Percutaneous radio-frequency ablation probe tumour-ablation monopolar	Class IIb
Open-surgery electrosurgical handpiece/electrode bipolar single-use	Open-surgery electrosurgical handpiece/electrode bipolar single-use	Class IIb
Peripheral vascular electrocautery catheter single-use	Peripheral vascular electrocautery catheter single-use	Class IIb
Epidural anaesthesia set non-medicated	Epidural anaesthesia set non-medicated	Class IIa
Soft-tissue biopsy procedure kit non-medicated	Soft-tissue biopsy procedure kit non-medicated	Class IIa
Side-notch biopsy gun handpiece/needle	Side-notch biopsy gun handpiece/needle	Class IIa