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EmbracePlus

by Empatica S.r.L. Italy EUDAMED510(k)GUDID

Ref EBP2-1G-SB-WModel EmbracePlus510(k) K242737

Product code MWIEMDN Z1203020601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00853858006546 UDI-DIDate16 Feb 2026ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK242737 Date6 Jun 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number0853858006EMBRACEPLUS44 Basic UDI-DIDate11 Nov 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
Empatica Health Monitoring Platform
Generic Name
Multiple vital physiological parameter monitoring system, home-use
Device Name
EmbracePlus
Model / Ref / Catalog
EmbracePlus, EBP2-1G-SB-W, EmbracePlus2 Silicone Band - White
Primary DI / UDI-DI
00853858006546
Basic UDI-DI
0853858006EMBRACEPLUS44
510(k) Number
FDA Product Code
MWI 510(k)
DQA GUDID
GZO GUDID
LEL GUDID
DRG GUDID
FLL GUDID
EMDN Code
Z1203020601 Complete vital signs telemetry systems
GMDN Term
Multiple vital physiological parameter monitoring system, home-use
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.2300 510(k)
870.2700 GUDID
882.1540 GUDID
882.5050 GUDID
870.2910 GUDID
880.2910 GUDID
Market of Registration
Italy
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

3 sources · 5 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
EmbracePlus
EBP2-1G-SB-W
510(k)
n/a
GUDID
EmbracePlus2 Silicone Band - White
510(k) NumberEUDAMED
n/a
510(k)
K242737
GUDID
K230457
FDA Product CodeEUDAMED
n/a
510(k)
MWI
GUDID
DQA
GZO
LEL
DRG
FLL
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II
Regulation NumberEUDAMED
n/a
510(k)
870.2300
GUDID
870.2700
882.1540
882.5050
870.2910
880.2910

Manufacturer details

EUDAMED SRN
IT-MF-000012905

Other devices from Empatica S.r.L.

See all devices from Empatica S.r.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 692035d0-3400-4c26-8392-b6353f06995e 61 fields · synced 24 Oct 2026
  • FDA 510(k) K242737 24 fields · synced 18 May 2026
  • FDA UDI 4e61c7bf-e8b9-47d7-bcfa-dff62464f886 35 fields · synced 22 Oct 2026