Question 1

What does Griffiths and Nielsen make?

Accepted Answer

Griffiths and Nielsen manufactures compression/pressure socks and stockings, including the Fitlegs Sport and Fitlegs AES models, which are single-use devices designed for therapeutic or supportive use.

Question 2

Where is Griffiths and Nielsen based?

Accepted Answer

Griffiths and Nielsen is based in GB, which refers to the United Kingdom, as indicated in the company's location data within the device registry information.

Question 3

Which regulatory registry lists Griffiths and Nielsen's devices?

Accepted Answer

Griffiths and Nielsen's devices are listed in the Eudamed registry, which is the European Union's medical device database used for tracking devices placed on the market in the EU and EEA countries.

Question 4

How are Griffiths and Nielsen's devices classified?

Accepted Answer

Griffiths and Nielsen's devices are classified as Class I under the EU medical device regulation, which means they are considered low-risk and subject to general controls, though individual devices must still meet conformity requirements before being placed on the market.

Device	Model / Reference	Registries	Class	Status
Fitlegs Sport	451000	EUDAMED	Class I	Active
Fitlegs AES	402006	EUDAMED	Class I	Active
Fitlegs AES	402004	EUDAMED	Class I	Active
Fitlegs AES	403000	EUDAMED	Class I	Active
Fitlegs AES	454001	EUDAMED	Class I	Active
Fitlegs AES	402007	EUDAMED	Class I	Active
Fitlegs AES	403002	EUDAMED	Class I	Active
Fitlegs AES	454003	EUDAMED	Class I	Active
Fitlegs AES	401001	EUDAMED	Class I	Active
Fitlegs AES	454000	EUDAMED	Class I	Active
Fitlegs AES	402001	EUDAMED	Class I	Active
Fitlegs AES	401007	EUDAMED	Class I	Active
Fitlegs AES	454004	EUDAMED	Class I	Active
Fitlegs AES	454002	EUDAMED	Class I	Active

Griffiths and Nielsen

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