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HL Healthcare Ltd

United Kingdom GB-MF-000004896 Last updated 23 May 2026

Devices
9
Registries
EUDAMED
FDA recalls
0

Catalogue9

Authorised representatives

What HL Healthcare Ltd makes

HL Healthcare Ltd manufactures a range of intranasal vaccines under the Vaxol brand, tailored for regional markets including Germany, Scandinavia, the Baltics, Croatia/Serbia, Poland, Czech Republic, Bulgaria, Hungary, Romania, and Slovakia. The company also produces intranasal products for ear health, including Earol and Baby Earol, designed for adults and infants respectively.

These devices fall under EU Class IIa classification and are registered in the EUDAMED database. HL Healthcare Ltd is based in the United Kingdom and adheres to EU regulatory requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does HL Healthcare Ltd manufacture?

HL Healthcare Ltd specialises in intranasal medical devices. Their portfolio includes intranasal vaccines under the Vaxol brand, which are tailored for specific regional markets such as Germany, Scandinavia, the Baltics, and several Central and Eastern European countries. Additionally, they produce intranasal products for ear health, including Earol for adults and Baby Earol for infants.

Where is HL Healthcare Ltd based?

HL Healthcare Ltd is based in the United Kingdom. Their headquarters and operations are located in Great Britain, where they develop and manufacture their range of intranasal medical devices.

Which regulatory registries list HL Healthcare Ltd’s devices?

HL Healthcare Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and monitor medical devices authorised within the EU, ensuring transparency and compliance with regulatory requirements.

How are HL Healthcare Ltd’s devices classified under EU regulations?

HL Healthcare Ltd’s devices are classified under EU Class IIa. This classification is determined based on factors such as the intended purpose, potential risks, and the body route of administration (intranasal in this case). Class IIa devices are considered to have a moderate risk and require compliance with specific EU regulatory standards and documentation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom(from SRN)
Address
The Courtyard, Eastern Road, Bracknell, United Kingdom (ex Northern Ireland)
PRRC contact
Kelly Lyon
EUDAMED SRN
GB-MF-000004896