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WatchPAT™ONE

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref AC2111801

by Itamar Medical Ltd.

Identity

Trade Name
WatchPAT™ONE EUDAMED
WatchPAT ONE FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
WatchPAT ONE EUDAMED
WatchPAT ONE for Canada FDA UDI
Model / Reference
AC2111801 EUDAMED
WatchPAT ONE (Canada) FDA UDI
Description
WatchPAT ONE for Canada FDA UDI

Identifiers

Catalog Number
AC2111801 FDA UDI
Primary DI / UDI-DI
07290109223254 EUDAMEDFDA UDI
Basic UDI-DI
729010922AC21508MX EUDAMED
510(k) Number
K183559 FDA UDI
K223675 FDA UDI
FDA Product Code
MNR FDA UDI
EMDN Code
Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

WatchPAT™ONE by Itamar Medical Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Itamar Medical Ltd.
EUDAMED SRN
IL-MF-000012046
Authorised Representative
Arazy Group GmbH DE-AR-000007685

Sources (2)

  • EUDAMED 33c51c8f-98c4-4445-a504-c2164f738733 61 fields · synced Jul 10, 2026
  • FDA UDI da211c1d-3286-4471-9271-b68f617aca5e 37 fields · synced May 30, 2026