ALLE S.R.L.
Italy IT-MF-000009969 Last updated 17 Sep 2026
- Devices
- 112
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
090355/E Ref 090355/E
270617 Ref 270617
SMS surgical gown Ref 270422
CPE waterproof overshoes Ref 270420
270902 Ref 270902
450010 Ref 450010
270640 Ref 270640
270626 Ref 270626
450018 Ref 450018
270607 Ref 270607
1091020 Ref 1091020
450013 Ref 450013
Spunbond green gown Ref 270425
450014 Ref 450014
450002 Ref 450002
270610 Ref 270610
090358/5/E Ref 090358/5/E
1091018 Ref 1091018
450023 Ref 450023
Sterile surgical drape Ref 2702XX
450016 Ref 450016
450001 Ref 450001
270616 Ref 270616
270602 Ref 270602
SMS surgical gown Ref 270423
Spunbond anti-slippery overshoes Ref 270419
Implantology Set Ref 2708XX
270624 Ref 270624
450021 Ref 450021
270603 Ref 270603
090354/E Ref 090354/E
270601 Ref 270601
450024 Ref 450024
Sterile dry paper towel Ref 270702
Tubing extension for mechanical irrigation Ref 270626
450004 Ref 450004
090313/220 Ref 090313/220
SMS pyjamas Ref 270416
SMS pyjamas Ref 270415
1091016 Ref 1091016
Sterile surgical sheath Ref 2703XX
090321/5/E Ref 090321/5/E
1091017 Ref 1091017
270637 Ref 270637
090357/E Ref 090357/E
450034 Ref 450034
Sterile set Ref 2701XX
Softesse® Expo model gown Ref 2704XX
270606 Ref 270606
450008 Ref 450008
Showing 51-100 of 112
What ALLE S.R.L. makes
Alle S.R.L. manufactures single-use medical textiles, including spunbond nonwoven gowns in light blue and surgeon caps, both spunlace and spunbond varieties. These items are designed for surgical and clinical environments to provide barrier protection and hygiene.
The company’s products are classified under EU Medical Device Regulations as Class I and Class IIa devices, with all relevant items registered in the EUDAMED database. The manufacturer is based in Italy.
Frequently asked questions
What types of medical devices does Alle S.R.L. manufacture?
Alle S.R.L. specializes in single-use medical textiles, including spunbond nonwoven gowns (like the light blue gown) and various surgical caps (such as spunbond round caps and spunlace surgeon caps). These products are designed for use in surgical and clinical settings to enhance barrier protection and hygiene.
Where is Alle S.R.L. based, and what does this mean for its regulatory compliance?
Alle S.R.L. is based in Italy, which means its medical devices are subject to EU Medical Device Regulations (MDR). Since the company’s products are listed in the EUDAMED database, they are intended for the European market and comply with the regulatory requirements applicable to Class I and Class IIa devices.
Which regulatory registries list Alle S.R.L.’s devices, and why is this important?
Alle S.R.L.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This listing confirms that the manufacturer has registered its products under the EU MDR, ensuring transparency and traceability for regulatory authorities and healthcare providers.
How are Alle S.R.L.’s medical devices classified under EU regulations?
Alle S.R.L.’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulations. This classification is determined by factors like the device’s intended use, risk level, and interaction with the body—with Class IIa indicating a moderate risk requiring additional safety measures.
Information
- Country
- Italy
- Address
- 1, Via Chizzalunga, Sandrigo, Italy
- Website
- euronda.com
- [email protected]
- PRRC contact
- Andre Nichele
- EUDAMED SRN
- IT-MF-000009969