Empatica S.r.L.

Italy IT-MF-000012905 Last updated 23 Oct 2026

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Devices: 23
Registries: EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls: 0

Catalogue23

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring Ref K260374

Class II FDA 510(k) Active
PKG Monitor by Empatica (iOS) Ref PKG-IOS

Class IIa EUDAMED Active
EmbracePlus with Elastic Strap Ref EBP2-1G-ES-F

Class IIa EUDAMEDFDA UDI Active
EmbraceMini FKM band Ref EMBM-1G-FB-B

Class I EUDAMEDFDA UDI Active
EpiMonitor sky blue Ref EPI-1G-FB-SB

Class IIa EUDAMED Active
Empatica Cloud Ref EMPA-CLOUD

Class IIa EUDAMED Active
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Ref K230457

Class II FDA 510(k) Active
Embrace Ref K181861

Class II FDA 510(k) Active
Embrace Ref K172935

Class II FDA 510(k) Active
Empatica Health Monitoring Platform Ref K221282

Class II FDA 510(k) Active
EpiMonitor milan black Ref EPI-1G-FB-MB

Class IIa EUDAMED Active
PKG Monitor by Empatica (Android) Ref PKG-AND

Class IIa EUDAMED Active
EmbracePlus Stretchable Band - Black Ref EBP2-1G-FB-B

Class IIa EUDAMEDFDA UDI Active
EpiMonitor by Empatica Ref EpiMonitor-AND

Class IIa EUDAMEDFDA UDI Active
EpiMonitor Flamingo pink Ref EPI-1G-FB-FP

Class IIa EUDAMED Active
Empatica Care Ref CARE-IOS

Class IIa EUDAMEDFDA UDI Active
EmbraceMini elastic strap Ref EMBM-1G-SB-B

Class I EUDAMEDFDA UDI Active
EpiMonitor by Empatica Ref EpiMonitor-IOS

Class IIa EUDAMEDFDA UDI Active
Empatica Care - Android Ref Care-AND

Class IIa EUDAMEDFDA UDI Active
EmbracePlus Ref EMBP-CC-MS

Class IIa EUDAMEDFDA UDI Active
EmbraceMini stretchable band Ref EMBM-1G-ES-F

Class I EUDAMED Active
EpiMonitor powered by EmbracePlus Ref EMBP-1G-SB-EM

Class IIa EUDAMED Active
EmbracePlus Ref EBP2-1G-SB-W

Class IIa EUDAMEDFDA 510(k)FDA UDI Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TUV Rheinland Italia SRL 1936 1 certificate

ITH 1986726 1 Supplemented

Quality management system EU MDR

Issued
11 Mar 2026

Expires
28 Nov 2029

Reason
Add device or group

Notified bodies

TUV Rheinland Italia SRL 1936

What Empatica S.r.L. makes

Empatica S.r.L. makes wearable health monitoring devices such as the Embrace series (including Embrace, EmbracePlus, and EmbraceMini), the PKG Monitor for iOS and Android, and the EpiMonitor in sky blue and Milan black variants. The company also provides the Empatica Health Monitoring Platform, Empatica Cloud, Empatica Care, and the Care Portal for data integration and remote monitoring.

These devices are classified as Class I, Class II, and Class IIa medical devices and are listed in the EUDAMED database and the FDA 510(k) registry. Empatica S.r.L. is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Empatica S.r.L. make?

Where is Empatica S.r.L. based?

Empatica S.r.L. is based in Italy, as indicated by the country code IT in the provided data.

Which registries list Empatica S.r.L.'s devices?

Empatica S.r.L.'s devices are listed in the EUDAMED database and the FDA 510(k) registry, as stated in the LISTED IN field of the device data.

How are Empatica S.r.L.'s devices classified?

Empatica S.r.L.'s devices are classified as Class I, Class II, and Class IIa medical devices, according to the DEVICE CLASSES field in the provided information.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Italy
Address: Via Stendhal, 36, Milan, Italy
Website: www.empatica.com
Email: [email protected]
PRRC contact: Alberto Poli
EUDAMED SRN: IT-MF-000012905
FDA FEI number: 3012933969

Catalogue23

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring Ref K260374

PKG Monitor by Empatica (iOS) Ref PKG-IOS

EmbracePlus with Elastic Strap Ref EBP2-1G-ES-F

EmbraceMini FKM band Ref EMBM-1G-FB-B

EpiMonitor sky blue Ref EPI-1G-FB-SB

Empatica Cloud Ref EMPA-CLOUD

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Ref K230457

Embrace Ref K181861

Embrace Ref K172935

Empatica Health Monitoring Platform Ref K221282

EpiMonitor milan black Ref EPI-1G-FB-MB

PKG Monitor by Empatica (Android) Ref PKG-AND

EmbracePlus Stretchable Band - Black Ref EBP2-1G-FB-B

EpiMonitor by Empatica Ref EpiMonitor-AND

EpiMonitor Flamingo pink Ref EPI-1G-FB-FP

Empatica Care Ref CARE-IOS

EmbraceMini elastic strap Ref EMBM-1G-SB-B

EpiMonitor by Empatica Ref EpiMonitor-IOS

Empatica Care - Android Ref Care-AND

EmbracePlus Ref EMBP-CC-MS

EmbraceMini stretchable band Ref EMBM-1G-ES-F

EpiMonitor powered by EmbracePlus Ref EMBP-1G-SB-EM

EmbracePlus Ref EBP2-1G-SB-W