Question 1

What types of medical devices does Lomed Nederland manufacture?

Accepted Answer

Lomed Nederland specialises in Class I medical devices focused on orthopaedic support and mobility. Their portfolio includes posture correction devices like the Posturex series, compression garments such as the Night Sock and hot/cold bandages for joints (e.g., knee and shoulder), as well as splints for fingers and toes. They also produce anti-slip gloves for arthritis relief and orthotic insoles like the Airwalker Pro-Orthic. These devices are designed to assist with mobility, joint support, and comfort for users.

Question 2

Where is Lomed Nederland based, and how does this affect its regulatory compliance?

Accepted Answer

Lomed Nederland is based in the Netherlands, which places it within the European Union’s regulatory framework. Since their devices are classified as Class I, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. This includes registration in the EU’s eudamed database, ensuring transparency and traceability of their products under EU law.

Question 3

Which regulatory registries list Lomed Nederland’s devices?

Accepted Answer

Lomed Nederland’s devices are registered in the eudamed database, the official EU registry for medical devices. This platform allows healthcare professionals, authorities, and patients to verify the legitimacy and classification of their products under EU regulatory requirements. Since all listed devices fall under Class I, they are subject to mandatory registration in eudamed.

Question 4

How are Lomed Nederland’s devices classified under EU regulations?

Accepted Answer

All of Lomed Nederland’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like orthopaedic supports, compression garments, and simple splints, which pose minimal risk to users. Class I devices still require compliance with EU regulations, including proper labeling, risk management, and registration in eudamed, but they do not require third-party conformity assessment (e.g., notified body involvement) unless they incorporate a measuring function.

Device	Model / Reference	Registries	Class	Status
Posturex - S	PO 31161 S	EUDAMED	Class I	Active
Night Sock White S	PO NS100W S	EUDAMED	Class I	Active
Reuma Handschoenen grijs maat S	IM AH260	EUDAMED	Class I	Active
Manulacer - S	PO 3119-B S	EUDAMED	Class I	Active
Buddy splint 19 mm	PO SP EZB02	EUDAMED	Class I	Active
Reuma handschoenen paars Anti slip maat L	IM AH312	EUDAMED	Class I	Active
hot/cold bandage knie	PO HCB003	EUDAMED	Class I	Active
Malleo Comfort	PO 31704	EUDAMED	Class I	Active
Finger Splint Joint-8 Size 14	APA SP W-51008145	EUDAMED	Class I	Active
hot/cold bandage schouder	PO HCB005	EUDAMED	Class I	Active
Posturex - XL	PO 31161 XL	EUDAMED	Class I	Active
Airwalker Pro-Orthic Maat XL	AW PO 1106 XL	EUDAMED	Class I	Active
Rom Elleboog Brace Pro-Orthic Links	EB PO 1105 L	EUDAMED	Class I	Active
Lumbo Basic - M	PO 31260-K M	EUDAMED	Class I	Active
Heel Cup	PO 31311	EUDAMED	Class I	Active
Genu Comfort - XL	PO 31701 XL	EUDAMED	Class I	Active
Polsbrace 8'' Rechts XS	PB PO 1101R XS	EUDAMED	Class I	Active
Reuma handschoenen grijs Anti slip maat S	IM AH270	EUDAMED	Class I	Active
Polsbrace 8'' Links M	PB PO 1101L M	EUDAMED	Class I	Active
Rib band - M	PO 31420-D M	EUDAMED	Class I	Active
Manu Stable Rhizo	PO 3121-F	EUDAMED	Class I	Active
Polsbrace 10 " Links L	PB PO 1106L L	EUDAMED	Class I	Active
Patella Basic	PO 31512	EUDAMED	Class I	Active
Terrypad Ii 48 cm	DV 99903	EUDAMED	Class I	Active
Lumbo Comfort Plus - XXL	Y060309	EUDAMED	Class I	Active
Malleo Comfort - XL	PO 31704 XL	EUDAMED	Class I	Active
Genu Airtex	PO 31603-ES	EUDAMED	Class I	Active
Genu Comfort	PO 31701	EUDAMED	Class I	Active
Polsbrace 10 " Links XL	PB PO 1106L XL	EUDAMED	Class I	Active
Malleo Lacer - M	PO 31751 M	EUDAMED	Class I	Active
Polsbrace 8'' Rechts M	PB PO 1101R M	EUDAMED	Class I	Active
Nacht spalk	NS PO 1102	EUDAMED	Class I	Active
Polsbrace 8'' Rechts L	PB PO 1101R L	EUDAMED	Class I	Active
Nacht spalk - L	NS PO 1102 L	EUDAMED	Class I	Active
Posturex - XXL	PO 31161 XXL	EUDAMED	Class I	Active
Lumbo Comfort Plus - L	PO 31275 L	EUDAMED	Class I	Active
Abdominal corset - XXL	PO 31420 XXL	EUDAMED	Class I	Active
Reuma handschoenen roze Anti slip maat L	IM AH292	EUDAMED	Class I	Active
TFCC Brace Rood	PO 319002	EUDAMED	Class I	Active
Genu Stable - S	PO 31708 S	EUDAMED	Class I	Active
Malleo Comfort - XXL	PO 31704 XXL	EUDAMED	Class I	Active
Manulacer - L	PO 3119-B L	EUDAMED	Class I	Active
Malleo Splint	PO 31755	EUDAMED	Class I	Active
Genu Stable - XXL	PO 31708 XXL	EUDAMED	Class I	Active
Manulacer - M	PO 3119-B M	EUDAMED	Class I	Active
Easy Sling	PO 31201	EUDAMED	Class I	Active
Pavlik Bandage	HB L 1620	EUDAMED	Class I	Active
Genu Comfort - XXL	PO 31701 XXL	EUDAMED	Class I	Active
Airwalker Pro-Orthic Maat S	AW PO 1106 S	EUDAMED	Class I	Active
Lumbo Comfort Plus	PO 31275	EUDAMED	Class I	Active

Lomed Nederland

About

What Lomed Nederland makes

Frequently asked questions

Information

Catalogue (217)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities