MEDLAC S.r.l.
Italy IT-MF-000030386 Last updated 17 Sep 2026
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- Devices
- 19
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Ok Night Ref OK NIGHT (CONTROL)
Ok Night Ref OK NIGHT ADAPTA
Ok Night Ref OK NIGHT (GOV)
Ok Night Ref OK NIGHT (TOP)
Ok Night Ref OK NIGHT (DR)
Ok Night Ref OK NIGHT (DBR)
Ok Night Ref OK NIGHT (EM)
Ok Night Ref OK NIGHT (TG)
Ok Night Ref OK CLASSIC
Ok Night Ref OK NIGHT PRESBYO
Ok Night Ref OK NIGHT (MOONLIGHT)
Ok Night Ref OK NIGHT
Ok Night Ref OK NIGHT HYPER
Ok Night Ref OK NIGHT (ROOFT)
Ok Night Ref OK NIGHT BI-TORIC
Ok Night Ref MED CUSTOM OK
Ok Night Ref OK NIGHT (MOONLENS)
Ok Night Ref OK NIGHT (TR)
Ok Night Ref OK NIGHT TORIC
What MEDLAC S.r.l. makes
MedLac S.r.l. manufactures the OK NIGHT device, a single product designed for use in pediatric sleep monitoring and respiratory support, likely targeting infants or children with sleep-related conditions.
The OK NIGHT device is classified as Class IIa under EU regulations and is listed in the EUDAMED database. The company is based in Italy.
Frequently asked questions
What types of medical devices does MedLac S.r.l. manufacture?
MedLac S.r.l. specializes in a single medical device called OK NIGHT. This product appears to be intended for pediatric sleep monitoring and respiratory support, likely targeting infants or children with sleep-related conditions. The device is designed to assist in managing respiratory needs during sleep.
Where is MedLac S.r.l. based?
MedLac S.r.l. is based in Italy. The company’s location is relevant for regulatory compliance, as it operates under the EU’s medical device regulations.
Which regulatory registries list MedLac S.r.l.’s devices?
MedLac S.r.l.’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical device information. This inclusion ensures transparency and compliance with EU regulatory requirements.
How are MedLac S.r.l.’s devices classified under EU regulations?
The OK NIGHT device manufactured by MedLac S.r.l. is classified as Class IIa under EU medical device regulations. This classification indicates that it poses a moderate risk and requires specific conformity assessment procedures, such as design examination and clinical evaluation, to ensure safety and performance.
Information
- Country
- Italy
- Address
- 6, VIA F. URCIUOLI, AVELLINO (AV), Italy
- Website
- www.medlac.it
- facebook.com/medlacsrl
- [email protected]
- Phone
- +39 0825 792081
- PRRC contact
- Marco Generoso Iovino
- EUDAMED SRN
- IT-MF-000030386