Unolab manufacturing, S.L.

Active in EUDAMED

Spainfrom SRN EUDAMED SRN ES-MF-000000272

Devices: 80
Registrations: EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union: EUDAMED actor, 1 certificate

What Unolab manufacturing, S.L. makes

Unolab manufacturing, S.L. produces sterile unit-dose ophthalmic and respiratory formulations, including eye drops (e.g., hyaluronic acid-based solutions and lubricating tears) and nasal saline solutions for pediatric use. Their portfolio includes pre-filled dropper bottles and ampoules designed for single-use administration in medical settings.

These products fall under Class IIb medical device classifications and are registered in the EUDAMED database. The company is based in Spain and adheres to EU regulatory requirements for sterile pharmaceutical formulations.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue80

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Company details

EUDAMED SRN: ES-MF-000000272
EU VAT number: ESB84749241
EUDAMED status: Active
EUDAMED registered name: Unolab manufacturing, S.L.
EUDAMED abbreviated name: Unolab
Registered address: 23, AVENIDA RITA LEVI- MONTALCINI, 28906, Getafe (Madrid), Spain
Website: www.unolab.es
LinkedIn: es.linkedin.com/company/unolab
Email: [email protected]
Phone: +34 910 888 288
PRRC contact: Noelia Guillén Belmar(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 19 Nov 2029

Notified body 0318 1 certificate

2024 CR 0040 Issued

Quality management system EU MDR

Issued
20 Nov 2024

Expires
19 Nov 2029

From the company website

Read 18 Oct 2026

Unolab is a global CDMO specialized in sterile unit-dose formulations using Blow-Fill and Seal technology, focused on ophthalmic and respiratory therapies.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Unolab manufacturing, S.L. have in the registry?

The registry currently lists 80 devices for Unolab manufacturing, S.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Unolab manufacturing, S.L.'s devices?

Among its 50 most recently registered devices, Unolab manufacturing, S.L. has devices listed in EUDAMED (50 devices).

What risk classes do Unolab manufacturing, S.L.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Unolab manufacturing, S.L.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Unolab manufacturing, S.L.?

EUDAMED lists 1 certificate for Unolab manufacturing, S.L. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2024-11-20.

What are the newest devices from Unolab manufacturing, S.L. in the registry?

The most recently registered devices listed for Unolab manufacturing, S.L. include Sanavita Collirio +day Monodose 10 x 0.4 mL, Mucoclear Protect 20 x 5 mL, Prontex Physio Water Soluzione Ipertonica 3% 20 x 5 mL and Nebu Pulmo 20 x 5 mL.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

EU certificates

Market reach

What Unolab manufacturing, S.L. makes

Catalogue80

Sanavita Collirio +day Monodose 10 x 0.4 mL Ref PSU-0013

Mucoclear Protect 20 x 5 mL Ref PSU-0081

Prontex Physio Water Soluzione Ipertonica 3% 20 x 5 mL Ref PSU-0071

Nebu Pulmo 20 x 5 mL Ref PSU-0083

Delphi-Mer HA 20 x 5 mL Ref PSU-0094

Naso Libero Inhalation 3% + HA 15 x 5 mL Ref PSU-0087

Silver Cross Soluzione Ipertonica Con Acido Ialuronico 20 x 5 mL Ref PSU-0091

Multinorm Inhalationslösung 30 x 2.5 mL Ref PSU-0105

Nebu-Dose Plus 5 x 5 mL Ref PSU-0089

Isomax Aerosol Soluzione Fisiologica 20 x 2.5 mL Ref PSU-0044

Isomax Naso Chiuso Soluzione Ipertonica 3% 20 x 5 mL Ref PSU-0067

Elysium Steril Hipertóniás Sóoldat 3% 20 x 5 mL Ref PSU-0006

WEPA NaCl 0.9% Inhalationslösung 20 x 2, 5 mL Ref PSU-0101

Nebu-Dose Hipertonic 30 x 5 mL Ref PSU-0068

Profar Soluzione Salina 3% 20 x 5 mL Ref PSU-0070

Prontex Physio Water Hyalu Soluzione Isotonica 0, 9 % 20 x 5 mL Ref PSU-0079

Sanavita Soluzione Ipertonica 3% 30 x 5 mL Ref PSU-0073

Nebu-Dose Hipertonic 5 x 5 mL Ref PSU-0069

Sofarmapiù Soluzione Isotonica 0.9% 20 x 2.5 mL Ref PSU-0060

Acofar Suero Fisiológico 30 x 5 mL Ref PSU-0036

Neostex Respire 7% + HA 30 x 5 mL Ref PSU-0097

Nebu-Dose Hialuronic 5 x 5 mL Ref PSU-0078

Knoxzy 3% + HA 20 x 5 mL Ref PSU-0093

Babywell Physiologische Kochsalzlösung (0.9%) 30 x 5 mL Ref PSU-0038

Ecto Respira 20 x 5 mL Ref PSU-0075

Isomar Flaconcini Fluidificanti Con Acido Ialuronico 20 x 5 mL Ref PSU-0085

Lloydspharmacy Soluzione Fisiologica 20 x 2.5 mL Ref PSU-0045

Elysium Steril Hipertóniás Sóoldat 7% + Hialuronsav 20 x 5 mL Ref PSU-0008

WEPA NaCl 0.9% Inhalationslösung 60 x 2, 5 mL Ref PSU-0102

Sofarmapiù Soluzione Ipertonica con Acido Ialuronico 20 x 5 mL Ref PSU-0092

Sopharmacy Физиологичен Разтвор 0.9% 15 x 5 mL Ref PSU-0061

WEPA NaCl 0.9% Inhalationslösung 20 x 5 mL Ref PSU-0099

Elysium Steril Hipertóniás Sóoldat 3% + Hialuronsav 20 x 5 mL Ref PSU-0084

Nasimer Soro Fisiológico 0.9% 30 x 5 mL Ref PSU-0050

Fornos Baby 20 x 5 mL Ref PSU-0062

Ser Fiziologic Laropharm 20 x 5 mL Ref PSU-0056

Nebu-Dose Baby 5 x 5 mL Ref PSU-0064

Elysium Steril Izotóniás Sóoldat 0.9% 20 x 5 mL Ref PSU-0005

Knoxzy 7% + HA 20 x 5 mL Ref PSU-0095

Nebu-Dose Isotonic 100 x 5 mL Ref PSU-0053

Saline Steridose 30 x 10 mL Ref PSU-0019

Eroski Suero Fisiológico 30 x 5 mL Ref PSU-0039

Alissa Healthcare Sodium Chloride Inhalation Solution 0.9% 20 x 2.5 mL Ref PSU-0037

Unidea Soluzione Salina 3% 20 x 5 mL Ref PSU-0074

Silver Cross Soluzione Isotonica 0.9% 20 x 2.5 mL Ref PSU-0059

IEA Medical Isotonische Kochsalzlösung 0.9% 20 x 5 mL Ref PSU-0043

Continente Do Bebé Soro Fisiológico 40 x 5 mL Ref PSU-0002

Aposán Botiquín Suero Hipertónico 3% 20 x 5 mL Ref PSU-0003

IEA Medical Isotonische Kochsalzlösung 0.9% 20 x 2.5 mL Ref PSU-0042

Naso Libero Inhalation 7% + HA 10 x 5 mL Ref PSU-0096

Company details

EUDAMED certificates1

Notified body 0318 ·1 certificate

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From the company website

Frequently asked questions

Notified body 0318 1 certificate