ALLE S.R.L.
Italy IT-MF-000009969 Last updated 17 Sep 2026
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- Devices
- 112
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Spunbond light blue cap with laces Ref 270504
Spunbond light blue gown Ref 270426
450006 Ref 450006
Spunbond light blue round cap Ref 270506
270623 Ref 270623
090314/T Ref 090314/T
Spunlace Surgeon Cap Ref 270502
090312/E Ref 090312/E
450036 Ref 450036
SMS surgical gown Ref 270424
1091019 Ref 1091019
450017 Ref 450017
270625 Ref 270625
270916 Ref 270916
270639 Ref 270639
450019 Ref 450019
450012 Ref 450012
450025 Ref 450025
Med-0300 Ref MED-0300
270638 Ref 270638
Adesivos esteriles Ref 270810
450029 Ref 450029
Spunbond green round cap Ref 270505
270636 Ref 270636
270906 Ref 270906
270634 Ref 270634
Irrigation set for machinery Ref 2709XX
270901 Ref 270901
450028 Ref 450028
450027 Ref 450027
Spunbond surgical gown Ref 2704XX
450003 Ref 450003
1091021 Ref 1091021
450032 Ref 450032
270635 Ref 270635
270618 Ref 270618
450033 Ref 450033
090358/E Ref 090358/E
450020 Ref 450020
090271/E Ref 090271/E
Manual irrigation set Ref 270630
450026 Ref 450026
270621 Ref 270621
270908 Ref 270908
450011 Ref 450011
Microfibre Expo model gown Ref 2704XX
270613 Ref 270613
450035 Ref 450035
450031 Ref 450031
450005 Ref 450005
Showing 1-50 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